Medical Progress Today
  Volume 1, Number 6
  August 19, 2004


In the Spotlight

Me-too Mythology
Robert Goldberg, Ph.D., 8-19-04

How many medicines are "enough" to treat a single disease like cancer, depression, or AIDS? Many critics of the pharmaceutical and biotechnology industries insist – without any supporting evidence – that just a couple of drugs in each therapeutic class for most diseases would be sufficient. They believe that companies producing anything beyond the first or second drug in a class are just making a rank attempt to keep profits flowing as older drugs go off-patent, without adding any real gains to public health.

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News

An experiment in globalisation - how India hopes to reshape the world drugs industry - PHARMACEUTICALS: Companies hope the country can build on its success in fields such as software and become a centre for innovation and research
Financial Times, 8-18-04

India's domestic pharmaceutical companies – long established leaders in generic drug markets – are girding themselves to challenge companies based in developed nations in the area of research-based drug development.

India already reaps enormous benefits from its abundant supply of low-cost, high-skilled labor in the IT sector – enough so as to cause tremors in the U.S. presidential election. But India also possesses similar advantages when it comes to the life-sciences industry – and those advantages are being leveraged by firms rushing to take advantage of India's implementation of the WTO's IP rules in 2005.

Under its current patent regime, Indian companies are allowed to sell generic versions of prescription drugs patented in other countries, provided they come up with a different manufacturing process. That will end in 2005, when India harmonizes its IP laws with WTO standards. As a result, Indian generic companies are racing to find other revenue streams and are shifting resources to directly compete with research based global giants like Pfizer and GlaxoSmithKline. Will they succeed?

Maybe, maybe not. But with significantly lower costs at home and companies in Europe and the U.S. facing ever greater regulatory pressures, Indian companies have to be taken very seriously as potential competitors.

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Health Journal: Latest Approach for Migraine Sufferers: Stopping Headaches Before They Start
Wall Street Journal, 8-17-04

The coming wave in medicine is prevention, with drug therapy used to forestall chronic diseases or reduce their severity when they do strike. Migraines, which affect about 30 million Americans, certainly fall into this category. The drive to prevent migraines is aimed at patients who regularly have multiple migraines every 30 days. Migraine prevention gained another tool this week when the FDA approved the epilepsy drug Topamax for migraine prevention, "bringing to five the total number of drugs approved by the FDA for migraine prevention."

FDA approval of Topamax for migraine prevention was based on two studies of 900 patients who suffered 4-8 migraines a month. In this placebo controlled study, "about half of the patients taking Topamax reported at least a 50% reduction in the number of monthly headaches." Other drugs can also be used to prevent migraines: propanolol and timolol (beta-blockers), divalproex sodium (an anti-convulsant), and the drug methysergide. All of the drugs work about as well as Topamax.

Does addition of Topamax to a crowded arsenal of migraine treatments make it a "me-too" drug, i.e. a useless addition to the public pharmacy? Probably not. The most widely used class of drugs used to treat migraine episodes, triptans, is ineffective for about 20-30% of patients, and overuse of the drugs can cause "medication overuse" headaches. For those patients who fail on traditional treatments, or who have frequent and severe migraine episodes, every alternative drug brings new hope for relief.

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RESPONSE TO SOARING COSTS: Prescription battle Lawmakers in West Virginia prepare to push for price controls placed on drugs as powerful pharmaceutical industry tries to defeat effort
Newsday, 8-16-04

West Virginia is considering legislative action to impose price controls on drug manufacturers, along with a range of other aggressive policies to lower the state's high drug costs. West Virginia is particularly hard hit by health care costs, since a significant portion of its population is elderly and in poor health – on average, residents take five more prescription drugs per day than other Americans.

Price controls would undoubtedly come with a cap on state spending in order to rein in costs. Patients would be shifted to older medications with more side effects before they were allowed to use newer, more effective (and expensive) ones. Thus price controls could, in the long run, quite possibly further damage the health of a population already laboring under other disadvantages. That is the option that West Virginia's policymakers should consider most costly.

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FDA worries that drugs could be a target for terrorists 'Chatter' hints at contamination of Canadian imports
Houston Chronicle, 8-15-04

Acting FDA Commissioner Lester Crawford has warned the nation that terrorist "chatter" gathered from around the world shows that terrorists are at least considering the possibility of poisoning America's domestic food or drug supply, "particularly illegally imported prescription drugs." Although the FDA and other federal agencies have long cautioned consumers that there is no way for regulators to guarantee the safety of drugs imported from abroad, this is the first official statement that terrorists are actively considering this as an avenue of attack.

Of course, terrorist "chatter" may be nothing more than idle talk – terrorists and their protιgιs undoubtedly consider a wide range of attacks, the vast majority of which never occur. Still, GAO and the FDA have uncovered ample evidence in recent months that drug importation is vulnerable to routine fraud and counterfeiting by unscrupulous firms – whether or not terrorists ever learn how to exploit these loopholes they are still there and we must learn how to close them.

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State prescription drug buying club not taking off as planned
Associated Press Newswires, 8-15-04

The government's prescription drug discount program is hitting some bumps in its early going. Some seniors find it confusing and hard to navigate. Critics allege that discounts in the program may not be as large as the government originally promised. Enrollment in the program is only a fraction of government estimates, and continues to lag despite the best efforts of government officials.

The Medicare discount card program? Hardly. The preceding description applies to Illinois's prescription drug buying club, touted by Governor Rod Blagojevich as a better alternative than its Medicare cousin. State officials had said that the program would help more than 1 million seniors and other residents save money – thus far, less than 14,000 seniors have paid the $25 annual fee to join the program.

We won't begrudge state officials their optimism regarding the future of their program while they are still working out its kinks – we only ask that they offer a similar courtesy towards the Medicare program.

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Donor Mistrust Worsens AIDS In Zimbabwe
The New York Times, 8-12-04

Zimbabwe's government under President Robert Mugabe has become increasingly corrupt, repressive, and violent in recent years – and NGO's and other international humanitarian organizations have found it harder and harder to work with the government without abetting its corruption.

Still, Zimbabwe is in the midst of an astounding AIDS crisis – with estimated 1.8 million people infected with HIV out of a population of 11 million; 360,000 people may need antiretroviral drugs now, while only a tiny fraction of that number can afford them. Should aid organizations withhold funding from Zimbabwe's people on account of the sins of its government?

This is a hard question. But it should also be noted that there isn't an infinite amount of AIDS funding to go around, and offering aid to countries that are more responsible – and effective – with that funding will save more lives in the long run.

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THE COLOR OF MONEY: Web Pharmacies Can Endanger Your Health and Wallet
Washington Post, 8-12-04

How can consumers tell whether or not an online pharmacy is legitimate? Answer: not easily. According to a survey conducted by the National Consumers League "most consumers purchasing prescription drugs over the internet don't know how to tell whether the drugs they get are legitimate." This finding parallels an earlier report by the General Accounting Office that many Internet pharmacies had questionable – if not downright illegal – business practices. Finding legitimate online pharmacies is certainly possible, but the savvy and growing technical skill of Internet counterfeiters makes ordering drugs online a risky proposition.

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Canadian pharmacies fill U.S. orders overseas
Star Tribune, 8-12-04

Drug makers have cut back on shipments to Canada in order to retain their ability to offer different prices in the U.S. and Canadian markets – in response to Canadian price controls and differing exchange rates. As a result, "in the past two months, at least five Canadian firms have arranged to fill U.S. orders for prescription drugs through pharmacies in Israel, Chile, Australia, England, France, Germany, New Zealand, Switzerland, Denmark, and Italy." Officials from the Canadian International Pharmacy Association have expressed concerns that pharmacies that ship drugs from far-flung suppliers are risking Canada's reputation for drug safety by relying on importers that may not meet Canadian standards.

The reality, though, is that if the U.S. legalized drug importation tomorrow and forced pharmaceutical companies to sell drugs to all comers this situation would worsen rather than improve. Widespread U.S. drug importation would send Canadian importers rushing to find cheaper suppliers to maximize their profits – and that means that Europe, South America, and Asia would all become prime suppliers for the American market in short order. If Canadian pharmacists have concerns about some of these suppliers, perhaps Americans should too.

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UA officials discussing proposed drug institute
Associated Press Newswires, 8-11-04

America's system of pharmaceutical and biotech innovation is the envy of the developed world – largely because America's patent system encourages academia to work with government researchers and private companies in the search for new medicines. The University of Arizona is one academic institution that wants to join this trend by working with the FDA to establish a drug institute on campus that would help the university guide new medical technologies from the lab bench to the bedside.

The FDA's work with the U of A is part of the FDA's "desire to speed the drug approval process by offering 'translational research' – and, bottom line, patient health can't be improved without better products reaching the market.

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Commentary

Fiddling Piano Keys While Africa Burns
Roger Bate, Richard Tren, Tech Central Station, 8-17-04

Malaria is the single largest killer of children in Africa — and accounts for over a million global fatalities every year. In 1998, the WHO, the World Bank, the USAID, and UNICEF launched Roll Back Malaria, a program whose noble goal was to cut malaria deaths in half by 2010. So far, malaria fatalities have risen by 12%. What happened?

There's a Cure for Frivolous Drug Lawsuits
Henry Miller, M.S., M.D., Los Angeles Times, 8-16-04

Pharmaceuticals are amongst the most heavily regulated and closely scrutinized products in the world. And yet, private lawsuits against the industry still hamper valuable research efforts and slow the pace of medical innovation. Creating a "regulatory compliance defense" for pharmaceuticals and similar products would help spur innovation in this critical industry.

Time for a Drug Test Registry
Marcia Angell, Washington Post, 8-13-04

It's hard to decide exactly where to disagree with Marcia Angell. On the one hand, she has a point: a national drug registry would help to disseminate useful clinical information and serve as a valuable research tool for physicians in their quest to give their patients the best medications possible.

On the other hand, she completely glosses over the fact that the clinical trial model she pillories relentlessly is not the brainchild of the pharmaceutical industry – it's been mandated by the FDA for decades. Her criticisms of large placebo-controlled clinical studies echo many of the same complaints from industry.

Everyone recognizes that these trials are a poor standard for vetting new medicines. Patients in these trials are too homogenous, the trials themselves are ridiculously expensive, and they don't mirror what physicians do in actual clinical practice. Overall, they don’t really tell us much about how drugs interact with patient health in the real world.

Pharmaceutical companies and the FDA are laboring intensely to come up with a better model for drug development: one that is faster, cheaper, and more accurate. But until we get there, blaming for the industry for clinical trial design is a bit like shooting the messenger because you don’t like what he told you.

Until we reach the point where we can perfectly predict in advance how a drug compound will interact with every individual's genotype – that is to say, never – drug development is going to be two parts science and one part luck. If Angell thinks that she has discovered an infallible, low-cost process for creating safe innovative drugs she ought to let us know – or better yet, patent it first, because then we can all benefit from her discovery.

Editorial: Africa's Health-Care Brain Drain
The New York Times, 8-13-04

Africa's health care system is in disarray, with its infrastructure degraded and its physicians and nurses demoralized from the myriad health crises affecting African nations. Not surprisingly, doctors and nurses are fleeing Africa for the developed world, where they can earn a decent living and offer a better future to their families.

The New York Times thinks that the solution is for developed nations, which benefit from this exodus, to "reimburse African health and educational systems for the cost of poaching their professionals." This is a noble idea that doesn't seem to take much account of context. African health care is in disarray because too many African governments are corrupt, lack transparency and accountability, and have lavished wealth on their vastly over-inflated military forces – all to keep themselves and their allies ensconced in power. As a result, too many African nations lack the fundamental social, legal, and regulatory infrastructure need underpin free markets and create wealth. Until African nations have the institutions that underpin economic success these problems will continue to thwart the best intentions of the New York Times editors.

From the analyst's couch: Statin switch to OTC
Martyn Link, Nature, 8-1-04

With national health care systems laboring under burgeoning health care costs and drugs showing clinical value for ever larger numbers of patients, governments are under increasing pressure to make some prescription-only medications available over the counter. This strategy may have the dual benefit of cutting government expenses and increasing public health; England's experiment making Zocor available OTC is merely the cutting edge in a growing transition to consumer driven health care.

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Research

Fluoxetine, Cognitive-Behavioral Therapy, and Their Combination for Adolescents With Depression
The Journal of the American Medical Association
August 2004

This study compared the relative effectiveness of fluoxetine (Prozac), cognitive-behavioral therapy, and placebo in adolescent patients with a diagnosis of major depressive disorder. The trial found that combination therapy (Prozac plus CBT) had the best response rate (71%) compared to Prozac alone (60%), CBT alone (43%) and placebo (35%). One interesting note given the recent hue and cry over a potential link between suicidal tendencies among adolescents and anti-depressant use: "Clinically significant suicidal thinking, which was present in 29% of the sample at baseline, improved significantly in all 4 treatment groups."

Assessment of Beneficiary Savings in the Medicare Drug Discount Card Program
The Lewin Group
August 2004

This study, conducted by the health care consulting firm The Lewin Group for the Healthcare Leadership Council, compared average savings for Medicare beneficiaries who shopped at retail pharmacies with the Medicare drug discount card to the retail prices they would have faced without the card. The study found that, nationally, the best discount cards offered about a 20% discount ($10 per prescription) to beneficiaries, with more than half of the cards offering savings of 17%.

This would mean that, for the life of the discount card program (until 2006, about 18 months) the best cards would offer savings of approximately $850 over retail prices. Per capita savings for low-income beneficiaries using the discount card (including the available $600 subsidy) would be over $1,500.

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Medical Progress Today is published by the Center for Medical Progress at the Manhattan Institute for Policy Research.

For more information about Medical Progress Today, please contact the managing editor, Paul Howard, at phoward@manhattan-institute.org, or via telephone at 212.599.7000, x319.

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HOME

SPOTLIGHT

Me-too Mythology

NEWS

An experiment in globalisation - how India hopes to reshape the world drugs industry - PHARMACEUTICALS: Companies hope the country can build on its success in fields such as software and become a centre for innovation and research
Health Journal: Latest Approach for Migraine Sufferers: Stopping Headaches Before They Start
RESPONSE TO SOARING COSTS: Prescription battle Lawmakers in West Virginia prepare to push for price controls placed on drugs as powerful pharmaceutical industry tries to defeat effort
FDA worries that drugs could be a target for terrorists 'Chatter' hints at contamination of Canadian imports
State prescription drug buying club not taking off as planned
Donor Mistrust Worsens AIDS In Zimbabwe
THE COLOR OF MONEY: Web Pharmacies Can Endanger Your Health and Wallet
Canadian pharmacies fill U.S. orders overseas
UA officials discussing proposed drug institute

COMMENTARY

Fiddling Piano Keys While Africa Burns
There's a Cure for Frivolous Drug Lawsuits
Time for a Drug Test Registry
Editorial: Africa's Health-Care Brain Drain
From the analyst's couch: Statin switch to OTC

RESEARCH

Fluoxetine, Cognitive-Behavioral Therapy, and Their Combination for Adolescents With Depression
Assessment of Beneficiary Savings in the Medicare Drug Discount Card Program
Center for Medical Progress 
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