Healthcare Outsider

One of the more interesting and bizarre crimes in recent memory occurred last month when several apparently professional thieves broke into the Eli Lilly warehouse (by cutting a hole in the ceiling!) and stole millions worth of prescription drugs (mostly antidepressants.) Since the most chemically imbalanced person in the world wouldn’t need this much Prozac, officials suspect that a sizable portion of the stolen stock will end up on the black market.

The New York Times reports that while some percentage of these pills will likely be sold for recreational use, there is evidence to suggest that the Eli Lilly drugs are currently being repackaged (cut, in some cases, with other drugs, or reduced in dosage) and resold in legitimate venues, usually without the knowledge of the pharmacy. While the warehouse theft was the first such incident to make big news in recent memory, the process of illegally re-marketing stolen drugs has been going on for years. These cases are often only discovered when patients report having had strange reactions to drugs they’ve been on for months, and further investigation identifies some additional chemical in the pills, or that they haven’t been stored in the proper conditions, which can alter composition and effects.

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The New York Times Reports that last month, GlaxoSmithKline (the pharmaceutical company that can do nothing right) recalled a popular dental adhesive called Super Poligrip from the market because it contained high levels of Zinc, and some people who used the cream had shown some adverse symptoms associated with the effects of Zinc poisoning (they were dying.) Zinc – you probably know it as the last ingredient listed on your unopened bottle of Centrum. You may also be familiar with its usage as an anti-corrosive, a component used to galvanize steel, and an adhesive agent in denture creams. What you probably didn’t know is that studies like this one (from the American Journal of Clinical Nutrition) have identified the metal as a toxic agent, and that long-term exposure to it can lead to nerve damage, anemia, and death.
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GlaxoSmithKline, the world’s second-largest drug maker, just can’t seem to catch a break.

It appears the Swiss pharma giant can do nothing right these days. First, there was Advair, the asthma drug that worsened the condition with prolonged use, then there was Avandia, the diabetes drug which has been shown to cause heart attacks. Now, there is GSK’s vaccine for the diarrhea-inducing virus Rotarix. The vaccine was found to contain traces of the supposedly innocuous pig disease called porcine circovirus.
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It’s not often that Pfizer or GlaxoSmithKline – two of the largest pharmaceutical companies in the world – make the news for something other than a scandal these days, but that’s exactly what happened last week when the drugmakers announced a 10-year deal to sell a large shipment of pneumococcal vaccine (fights pneumonia and meningitis) to developing nations at a dramatically cheaper price than consumers in the first world are paying. The price for the drugs normally run from $54-$110 (depending on the dosage) and are being offered at a range of $3.50 – $7.

Could this be a sign of a more magnanimous pharma industry? Perhaps drug makers will begin offering the desperately-needed AIDS cocktails at a reduced price. No one should hold their breath on this. [Reuters]

-Michael B. Sauter

There are twelve major pharmaceutical and biotech firms which dominate the industry worldwide. Their combined market value is over $1 trillion with total  annual sales  of over $500 billion. These firms have developed and marketed most of the global blockbuster drugs. Most of the significant actions take by the FDA and other drug and medical device regulatory bodies involve the medications, devices, and vaccines developed by these firms.

The big twelve companies are  also involved in most of the large product liability actions and class action suits regarding prescription drugs. The largest pharmaceutical firms spend tens of million of dollars in legal fees and lobbying expenses every year to protect the intellectual property they have created and defend themselves when their products have unintended side effects.

The twelve CEOs on this list – the global drugs lords – operate in a heavily regulated industry and have close and often fractious relationships with the governments whose agencies work with them. HCO has looked at each company, its blockbuster drugs, and  its most valuable board members. These members are often not the most well-known people on the boards. They are, however, individuals from the medical community, former regulators, academicians involved in the medical research world, and fixers who serve on large numbers of boards and whose contacts in the world of government and industry are invaluable.

The drug industry is under seige by generics and rising costs of R&D. Many of  the companies on this list have been though substantial restructuring and have fired tens of thousand of people, cutting R&D budgets in the process. This generation of CEOs and board members will shape the rapidly changing industry more than any other group in decades. We will now look at a brief snapshot of the twelve juggernaut companies these men run, the major drugs they produce, and the board members that allows their company to navigate the policy arena.

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It is becoming clear the gods of pharmaceutical industry hate GlaxoSmithKline with a passion. As if the drug producer wasn’t having enough problems with Advair, its apparently counterproductive asthma drug, intense controversy continues to brew in the FDA over GSK’s diabetes pill, Avandia. While the administration hasn’t come down one way or the other on the subject, several FDA studies have determined that Avandia causes hundreds of unnecessary heart attacks each year, and that it should be taken off the market entirely. These reports also point to the fact that diabetics could easily get the same treatment and avoid the ridiculous possibility of heart failure simply by switching to a comparable drug, Actos. [NY Times]

Advair, Avandia, Actos. Why does every newsworthy drug this week start with an A? The obvious answer: the FDA is so backlogged in reviews, it hasn’t made it past the first letter of the alphabet.

-Michael B. Sauter

A few days ago, the results of a study entitled “Aspirin Intake and Survival”  was published in the Journal of Clinical Oncology. Within 24 hours, the findings of the report – which pointed to the household painkiller as a possible miracle drug in breast cancer treatment – were being heralded in all the major media as one of the most significant medical breakthroughs in months. The 30-year observational report, conducted by over 4,000 nurses from around the country, determined that  female patients who regularly took Aspirin in conjunction with their treatment had a 50% better survival rate than those who did not. To be sure, if these numbers are accurate, this is a major breakthrough in the way we treat the deadliest form of malignancy among females, and the second-deadliest overall (after lung cancer.)

Before we all breathe a sigh of relief and afflicted women and those who believe they may be at risk head to Costco to buy the painkiller in bulk, we should be very sure we understand what this study really means, and how seriously we want to take the results. Most importantly, we should understand what doctors are saying about the study.

In an article released in the women’s health blog womensvoicesforchange.org, Dr. Bonnie Reichman, an oncologist at the Cornell Medical Center, considered the merits of the study and its implications. She explained that the general consensus among oncologists at the moment is one of tentative optimism. “This is an observational study,” she explained, “relying on self-reporting of aspirin use four years after breast cancer diagnosis – the results are suggestive, mind you, not conclusive, of the possible benefit of taking aspirin in preventing distant recurrences … and deaths due to breast cancer.”  She added that Doctors believe that the anti-inflammatory effects of the medicine the likely cause of Aspirin’s apparent mollification of the cancer.

Despite a certain level of optimism, Reichman, like many other physicians, stress that we approach these results with caution. She explained that while it is an over-the-counter medication “Aspirin is not a benign drug and can cause bleeding, especially from the stomach.” While the data remains as tenuous as it currently is, we shouldn’t think of the drug as a foregone conclusion that every afflicted patient should begin taking right away, but it certainly should be considered – with the consultation of the patient’s oncologist – as part of their comprehensive treatment plan. “At this time” she concluded, “routine use of Aspirin is not indicated—and won’t be, until these interesting results are confirmed in a properly conducted prospective trial.

A link to Reichman’s Article can be found here: womensvoicesforchange.org

-Michael B. Sauter

The FDA warned yesterday that Advair, an commonly prescribed asthma medication from pharmaceutical company GlaxoSmithKline Plc. , should not be used in the long-term because, Bloomberg reports, they contain long-acting beta agonists, which “have been linked to increased risk of worsening asthma symptoms, hospitalizations and deaths.” As you might expect, this has had some negative effects on the sales of the drug, as most asthma patients want their conditions to “improve” and not “worsen,” but makers of the drug insist that it is a perfectly viable solution for short-term treatment of the respiratory disease.

-Michael B. Sauter

The FDA continued is blundering and fumbling of as the protector of the American public from big pharma. The New York Times reports that “American consumers are waiting nearly a year longer for government regulators to approve new lower-priced generic drugs than they did in 2005.” Put another way, people who need access to prescription drugs pay billions of dollars a year more than they have to and this pushes health-care costs up. The expense of an increase in the FDA staff to shorten the process would be much less expensive that the cost of the delays in getting generics to market.

The Times reports that the head of the FDA said that “The generics industry has saved consumers nearly $750 billion over the last decade, Dr. Hamburg said at the conference. ” read more »

You may remember HCO doing a piece a few days ago about potentially troubling things happening to PhRMA, the central lobbying group of the major American drug companies. The industry, we explained, was in a state of minor panic for fear of what legislation might come out of the void of the imploding goat rodeo that is the democratic reform bill. Now, it seems, the proverbial feces is hitting the proverbial fan.

Former Congressman Billy Tauzin announced his resignation as CEO of PhRMA, citing a desire to explore “other interests.” Of course, the likelihood of that being his actual reason for leaving is pretty close to zero percent. All right, so other than the fact that being the chief lobbyist for an interest that’s on the brink of being screwed is never a desirable position to be in, how might we explain our man’s sudden departure? Before the world turned upside down and massachusstets elected one-time nude model scott brown, Tauzin recognized that the democrats were running the show, and saw that if the industry had any chance of surviving, it might be a good idea to be a party to the negotiations.

A few months, a Massachussetts election, and a presidential admission of potential bill failure later, and PhRMA has ousted their former chief for siding with a party traditionally considered an enemy of the industry.

-Michael B. Sauter