Friday, April 5, 2013
Friday, April 5, 2013

Filed Under: Daniel Hoffman
POSTED: Friday, April 5, 2013, 7:00 AM

Hardly a day goes by without the stock prices of one or more Big Pharma companies reaching a 52-week high.  Of the nine Big Cap pharmas covered by Sanford Bernstein, they rate six as Outperform (i.e., Buy) and three as Market-Perform (amounting to Hold). 

Also this week Citigroup reported that in February, EU-based Big Cap pharmas outperformed the market by 5% while US-based Big Caps ran 6% ahead.  Smaller specialty pharmas, both here and in Europe, performed comparably ahead of other sectors.

At the same time that pharma's stock prices are soaring, the results show 2012 total sales for most Big Pharmas were down and actual sales for several 2012 launches, to this point, have totaled well below their estimates.  Some examples will make the point (see here):

  • GlaxoSmithKline's 2012 sales for prescription products were 1% below the previous year;
  • Novartis's 2012 sales were essentially flat, showing a 0% change from 2011 in constant currencies
  • Sanofi's pharma sales last year declined by 0,4% in constant currencies;
  • Merck sales in 2012 fell 1%, excluding foreign currency exchange values;
  • AstraZeneca ended 2012 with sales more than $5 billion below the previous year;
  • Bristol-Myers Squibb took a 17% hit to sales last year.
Daniel R. Hoffman, Ph.D. @ 7:00 AM  Permalink | Post a comment
Filed Under: Daniel Hoffman
POSTED: Thursday, March 28, 2013, 6:00 AM

In 2003 Gerard Anderson of Johns Hopkins University and Uwe Reinhardt from Princeton, together with two of their colleagues, published a study that concluded Americans pay health care costs that are as much as four times higher per person than other advanced countries.  Just this week, the International Federation of Health Plans (IFHP), a global trade association of insurers, updated those findings by concluding that the disparity has even worsened, so Americans now pay even comparatively more.  The question is, why are costs here so much higher?

Anderson and Reinhardt asked that question and answered it in the title of their 2003 paper: "It's the prices, stupid."  They first examined other plausible factors that could conceivably account for higher US health care costs.  These included suggestions that Americans are sicker or visit doctors and hospitals more often or have longer hospital stays.  All of these diversionary explanations, offered by apologists for our system, are bogus.  American hospital stays, for example, are shorter than those in Germany, while we visit physicians less often than Canadians.   Yet Germany's per capita health care cost is about half of what the US pays, while Canada's is 60% of ours.

So why are prices so much higher here?  Anderson told the Washington Post's Ezra Klein, “Other countries negotiate very aggressively with the providers and set rates that are much lower than we do.”  They do this either by the government setting prices, as in Britain and Canada, or by insurers aggressively negotiating with providers, as in Germany and Japan, while their governments reserve the right to set prices if the two sides fail to reach a satisfactory agreement.

Daniel R. Hoffman, Ph.D. @ 6:00 AM  Permalink | 1 comment
Filed Under: Daniel Hoffman
POSTED: Wednesday, March 20, 2013, 6:00 AM

An email from a reader last week contained a link to an article (see here) about the FDA's proposal to ease the efficacy and safety standards for approving new Alzheimer's drugs.  His terse comment was, "If it goes through, it will open great opportunities for snake oil salesmen."

His brief remark was on target.  When a society depends upon a competitive market to develop its new therapies, a proportion of snake oil salesmen will inevitably enter the mix.  That applies especially to conditions such as Alzheimer's, where the precise disease mechanism remains open to question and even a diagnosis depends upon an imprecise combination of imaging, laboratory and behavioral screens.  That kind of uncertainty applied to most conditions in the 19th century.  As a result, charlatans went around in covered wagons selling snake oil to farm towns and mining camps. 

But jeopardizing the rest of society in order to make a buck is the holiest of core values in this country, so don't expect things to change anytime soon.  For example, Judy Segal from the University of British Columbia compared old advertisements for nineteenth century potions to contemporary ads for prescription pharmaceuticals.  While the ads for miracle elixirs and nostrums claimed to relieve such symptoms as fatigue, nervousness, constipation and general disappointment with life, "Drug ads today," according to Segal, "are much the same."  Ads for Lydia Pinkham’s vegetable compound played on the same moodiness theme as Yaz, the same menopausal symptoms as Premarin, and the depression that Zoloft promises to dispel.

Daniel R. Hoffman, Ph.D. @ 6:00 AM  Permalink | Post a comment
Filed Under: Michael Cohen
POSTED: Tuesday, March 12, 2013, 7:00 AM

In Chicago last month 16 elementary school children were taken to local hospitals with a sudden illness. The children were 9- and 10-year olds who began vomiting after eating “mints” given to them by a classmate. It was later found that these “mints” were actually nicotine replacement lozenges, called NiQuitin Minis. NiQuitin is a product from the United Kingdom that is sold online. Nicorette, which is made in the US, has a similar product. These are used by people who want to stop smoking. The classmate had found the lozenges at home and brought them to school to share.

These lozenges look very similar to candy breath mints like Tic Tac. The size and shape of the container is similar to other breath mints, and the container does not have a child-resistant cap.

You can see why children might assume that the “mints” were candy. Fortunately, none of the children were seriously hurt.

Michael R. Cohen, R.Ph. @ 7:00 AM  Permalink | Post a comment
Filed Under: Embarrassing Questions
POSTED: Monday, March 11, 2013, 9:43 AM

I'm in my 30s and starting to notice some of my teeth are yellowing. Is this normal? What are safe ways to whiten? Is there anything that I can do the slow down the yellowing?

Markus B. Blatz, DMD, PhD, is a professor of restorative dentistry, and chairman of the department of preventive and restorative sciences at the University of Pennsylvania, School of Dental Medicine

Natural teeth have a tendency to get darker as we get older. There are several more or less effective over-the-counter tooth whitening products and toothpastes available in drug stores and pharmacies that may be helpful in making your teeth lighter again. The most effective and safest way, however, is to do this under the supervision of a dental professional, who can assess the reason for the darkening and select the most appropriate solution.

The teeth may be discolored with “external” stains from tea, coffee, tobacco, red wine etc., which can only be removed with special cleaning and polishing instruments, preferably by a dentist or dental hygienist. If that’s the case, this cleaning should be done before any other tooth whitening procedure.

@ 9:43 AM  Permalink | Post a comment
Filed Under: Daniel Hoffman
POSTED: Monday, March 4, 2013, 9:50 AM

Big Pharma has been keeping itself afloat for some time on a number of myths.  For several years, as investors saw the industry's business model breaking down, pharma tried to assuage them by perpetrating the myth that the emerging global markets (China, India, Russia) will restore earlier profit levels.  Then in response to the general public's complaint about high drug prices, pharma spread the myth that such exorbitance is needed to fund research.  More recently pharma has shown the vacuity of the myth that it is downsizing and decentralizing its operations in such a way that it can approximate the innovativeness, mobility and accountability of smaller biotechs.

If that last one ever contained even the slightest plausibility, recent events have shown it to be pure myth.  Of course, the idea of large corporations with their soul-killing accountants and time-wasting procedures as impediments to creative science makes axiomatic sense.  So it seems reasonable if Big Pharmas, trying to distract from the mediocrity of their new brands, would want to show they're at least trying to justify their enormous margins by modifying operations to develop better drugs.  Pharma's leaders can then boast that they possess the good aim to hit the broad side of a barn by virtue of their desire to emulate the industry's smaller companies. Innovation and a fervid devotion to research are good qualities, after all, not to mention the fact that biological drugs are more immune to steep revenue losses when their patents expire.

Toward that end, GlaxoSmithKline (GSK) announced a few years ago that it was separating its R&D into several silos, giving the collectivity a chamber of commerce designation as Centers of Excellence.  The idea was that each unit would need to demonstrate the accountability for results and the fervor of inspired biotechs.  Shortly afterward GSK recognized that some excellent centers could prove to be mediocre, so they decided to fund the silos with reviewable grants instead of annual budgets. 

Daniel R. Hoffman, Ph.D. @ 9:50 AM  Permalink | 2 comments
Filed Under: Michael Cohen
POSTED: Monday, February 25, 2013, 9:56 AM

Opioid patient pack in FinlandWe get a lot of complaints from consumers who tell us their pharmacy shorted them on the number of tablets or capsules they were supposed to get when they had their prescription filled. A report we got last week is typical. A young patient who had dental surgery received a prescription for the opral opioid Lortab 7.5 mg. The amount the dentist listed on the prescription was 24 pills. The patient’s mom had the prescription filled at a local pharmacy. Then, later on at home she counted only 21 pills. Mom called the pharmacy because she wanted to make sure the pharmacist was aware that a mistake had been made in the count. But the pharmacist became defensive, even suggesting that her daughter must have diverted the pills.

Nearly all of the complaints we get like this involve opioid narcotic prescription products like Oxy-Contin, Vicodin, Lortabs, etc. The pharmacy always seems to say that the patient or someone in their home removed some tablets (either for themselves or even to sell on the street) and the patient says the same about the pharmacist and/or their staff. In truth, research shows that diversion through “shorting” (undercounting) and pilferage by pharmacists and pharmacy employees does take place and it’s not that uncommon. At the same time, pill-abusing middle- and high-school students are often obtaining their drugs through medicine cabinet thefts. So really, it’s essential that we find better ways to control these drugs.

The importance of preventing drug diversion is a constant concern. It came to light again last week when the CDC reported that drug overdose deaths in the US rose for the 11th straight year in 2010. There were 38 329 deaths with 22 134 (57.7%) involving pharmaceuticals. Three-quarters of those were unintentional and, not surprisingly, prescription opioid narcotics like those above were responsible for 75.2% of the involved drugs! It’s time we took a hard look at the way these drugs are commonly dispensed in the US. We make it way too easy for people who abuse drugs.

Michael R. Cohen, R.Ph. @ 9:56 AM  Permalink | 1 comment
Filed Under: Daniel Hoffman
POSTED: Tuesday, February 19, 2013, 9:00 AM

Last summer UC Berkeley professor Robert Reich reflected on the $3 billion penalty GlaxoSmithKline (GSK) paid for a whole range of violations.  Their criminal behavior that led to the fine included: promoting an antidepressant approved only for adults to kids under 18; selling two other antidepressants for unapproved purposes, including sexual problems and; currying prescriptions by lavishing physicians with expensive gifts.

Professor Reich correctly noted that seemingly large fines such as this or the $2+ billion Pfizer paid a few years earlier won't deter pharma's criminal behavior.  GSK sold $27.5 billion worth of the three anti-depressants during the years of their malfeasance and, besides, shareholders pay the fines anyway.  The managers who devised and supervised the illegal behavior didn't have to pay a dime and they weren't hauled into criminal court.  In the unlikely event some shareholders attempt to chastise them, the disparity between the amounts of revenue and the penalty enable them to rationalize the fine as a mere cost of doing business.

Skepticism about the deterrent value of fining pharma companies is well placed.  Since the middle of last year, several more entries have appeared on this police blotter for pharma crime.  Each case was resolved with a pharma paying a fine in the hundreds of millions or the billions, yet the violators keep adding to the industry's rap sheet.  After Professor Reich predicted the GSK wouldn't lead to less law breaking, Amgen and Johnson & Johnson were nabbed for rigging the erythropoietin market (see here and here), Johnson & Johnson paid another $1.2 billion for bribing to push Risperdal sales, GSK faked a citizen petition, Pfizer acknowledged bribing foreign physicians, as well as a raft of other illegal practices.

Daniel R. Hoffman, Ph.D. @ 9:00 AM  Permalink | 3 comments
Filed Under: Embarrassing Questions
POSTED: Monday, February 18, 2013, 10:47 AM

My girlfriend just found out that she has HPV. What is it? What does this mean for me?

Jie Xu, M.D, specializes in OB/GYN at Riddle Hospital, Main Line Health.

HPV, which stands for human papillomavirus, is the most common sexually transmitted infection and is passed on through genital contact. There are over 100 types of HPV. The most common types causing genital warts are types 6 and 11, and for cervical cancer, types 16 and 18. What most people do not realize is that HPV usually has no signs or symptoms, so those who are infected may not know that they have it and may not realize that they are passing it on.

Although your girlfriend was diagnosed with HPV and you may have already contracted it, both of you can still be vaccinated. The vaccine protects you against more than just one type of HPV. Make an appointment to see if you are eligible for a vaccination to protect yourself and prevent the potential spread of the infection.

@ 10:47 AM  Permalink | 3 comments
Filed Under: Michael Cohen
POSTED: Monday, February 18, 2013, 10:18 AM

Vaccineinformation.org is the most comprehensive offering I’ve seen for patients and families interested in getting accurate, scientific, up-to-date information about immunizations. It’s like a one-stop shop for learning about diseases and how they can be prevented by vaccination.

The website provides basic information about vaccines, such as how they work, their importance, and the resources you can trust for information, including the Vaccine Education Center at Children’s Hospital of Philadelphia. There’s a vaccine safety section and there’s even a tool to help you find where to get vaccinated. A “Disease” section provides useful information about preventable diseases and their associated vaccines.

The main feature on the website provides details about needed vaccines arranged by age group, for infants and children, preteens, teens, and adults. You’ll get an explanation about the significance of each when you click on it and there are personal testimonies of suffering and loss due to associated preventable diseases.  There’s also asearchable collection of videos and public service announcements that can be accessed for each age group.

Michael R. Cohen, R.Ph. @ 10:18 AM  Permalink | Post a comment
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