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I have refrained from commenting on healthcare reform until now because there wasn’t much I could add to the debate. That said, while reading an article in a local paper on bacterial antibiotic resistance and how to minimize it, the author—an infectious disease doc—offered a telling statistic that identified the root problem with our current healthcare system. According to the article, 65% of the time, physicians will prescribe antibiotics to patients suffering from upper respiratory tract infections who demand them, whether or not they are warranted. In marked contrast, 12% of patients with upper respiratory tract infections who don’t ask for antibiotics receive antibiotic prescriptions. The bottom line: physicians give patients the drugs and treatment they demand because they are afraid of losing them as customers knowing full well the patients will go to another physician who will give them what they want! After all, physicians are in business and to stay in business they need to make enough money to cover their overhead and make a profit. However, over prescribing antibiotics is one of the main reasons why we are in the midst of an epidemic of infections caused by multiple drug resistant bacteria. In my opinion, business outcomes should never supersede or trump medical or public health outcomes.

Don’t get me wrong, I am an entrepreneur and believe that people with good ideas ought to be rewarded for their efforts and make as much money as they can. However, in my opinion, for profit business practices and healthcare haven’t historically worked well for the American healthcare system. Removing profit incentives from healthcare would be an important first step to begin to repair our broken healthcare system. Can anybody say public option?

Until next time...

Good Luck and Support the Public Option!!!!

 

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The media frenzy surrounding the impending H1N1 swine flu pandemic has spawned a recent spate of articles and television news segments on “germs.” In the last 48 hours, articles on germs have appeared in the New York Times, my local paper (The Trenton Times via the Chicago Tribune), on news channels and most recently this morning on the Today Show on MSNBC. Most of these have focused on where “germs” are found, how they are spread and ways to minimize or prevent their transmission. For those of you who may be interested, the word germ was first coined in 1664 and is defined as a “small mass of living substance capable of developing into an organism or one of its parts” or more conventionally, as a “microorganism that causes disease.” While these media pieces are intended to inform the public about infectious agents and their transmission, most people who read or see these reports don’t understand that the word germ can encompass viruses, bacteria and fungi. And, to make matters worse, most Americans don’t know that viruses, bacteria and fungi are different microorganisms.

Unfortunately, after reading newspaper articles and seeing reports on television about so-called germs, many consumers rush out to their local groceries and purchase a variety of antibacterial soaps and detergents—erroneously believing that these products will protect their families from infection by the dreaded H1N1 virus and other pathogens. Although frequent hand washing and the appropriate use of viricidal disinfectants can help to reduce transmission of H1N1 and other viruses, antibacterial products are generally less effective (or ineffective) against viruses and overuse can result in emergence of multi-drug resistant bacteria.

To that end, I think it is high time that the news media eschew the use of the anachronistic term germ in favor of bacteria, virus or fungi when referring to causative agents of infectious diseases. Promulgating the use of the word germ will continue to keep the lay public in the dark about infectious agents and the diseases they cause and hinder people from making informed decisions about treatment and preventing their transmission.

Until next time...

Good Luck and Good Job Hunting!!!!

 

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News Day reported today that Wegmans Food Markets, a grocer with 72 locations in New York, Pennsylvania, New Jersey, Virginia and Maryland is giving away “free generic antibiotics” for customers (with a prescription). Wegmans joins a growing list of supermarkets pharmacies including Giant Food and Publix that are giving free generic antibiotics to its customers.

I first learned about the “free generic antibiotic give away offers” several weeks ago after reading a post on the Wall Street Journal (WSJ) Health Blog. I took the WSJ health blog to task for posting the story without editorial comment on the potentially dangerous practice of “hawking free antibiotics” to drive business at regional and nationwide grocery store pharmacies. Luckily, in today’s WSJ Health Blog post about the Wegmans program, the author (Sarah Rubenstein) did suggest that the practice may lead to unnecessary promotional  use of antibiotics.

As you all should know by now, we are in the midst of bacterial antibiotic-resistance epidemic. People are beginning to regularly die from bacterial infections that were easily treatable a decade ago. Ironically, we are slowly approaching the morbidity and mortality rates for bacterial infections that previously existed in the pre-penicillin era. Moreover, there are no new, orally bioavailable, broad spectrum antibiotics on the horizon. A lack of new antibiotics coupled with rapidly emerging resistance to extant ones is wreaking havoc on the healthcare system in both community and hospital settings.

The “free generic antibiotics” advertising and marketing programs concocted by Giant, Publix and Wegman’s are egregious examples of how a lack of or unwillingness to understand science poses a serious public health threat to all Americans. I have no doubt that the marketers who devised the give away programs have nary a clue about the relationship between antibiotic use and the emergence of antibiotic resistance strains of bacteria. Further, while physicians may be aware of increasing rates of antibiotic resistance, many are reluctant to not prescribe antibiotics to patients who request them. After all, these physicians are running a business and if they don’t write the script, the patient will take his/her business elsewhere. The potential public health implication of these free antibiotic programs begs the question: Why not give away generic ace inhibitors, generic statins or other generic medications whose profits margins are also negligible but don’t carry any public health risks?

Put simply, the promise of free generic antibiotics is a marketing strategy that is in my opinion, reckless, dangerous and may have serious public health implications in the future. Make no mistake about it, I am a capitalist but not when profits are placed before human lives.

Hat tip to the WSJ Health Blog

Until next time…

Good Luck and Good Job Hunting (try antibiotic drug discovery—we need new ones)

 

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Pfizer announced today that it would withdraw marketing application being considered at FDA and the European Medicines Agency (EMEA) for Dalbavancin an antibiotic it was developing for complicated skin infections caused by bacteria including methicillin-resistant Staphylococcus aureus (MRSA).

Pfizer acquired Dalbavancin after it purchased California-based Vicuron Pharmaceuticals for $1.9 billion in 2005. At that time, Vicuron had filed an NDA with FDA and had expected approval for the novel antibiotic. Instead, after acquiring Vicuron, Pfizer received an approvable letter from FDA that requested additional studies before the agency would approve the drug. Based on the agency’s comments, Pfizer decided to withdraw the original US and European applications filed by Vicuron and conduct addition Phase III clinical trials for the complicated skin and soft tissue infection and pediatric indications. I suspect that results from these trials will determine whether Pfizer files new applications with FDA and EMEA for Dalbavancin.

For those of you who may not know, Vicuron Pharmaceuticals was formerly called Versicor, a company founded by Eric Gordon, Mickey Gorman and others. In 1996, I was recruited to interview for a Vice President of Biology position at the company.  At that time, Versicor had about 15 employees — Eric was CEO and Mickey was a consultant.  Although Eric, Mickey and I became fast friends, I didn’t get the job (they never hired anybody for the position). 

Both Eric and Mickey left Versicor a couple of years later. Eric went on to start Sunesis, a very successful Bay area oncology company and Mickey retired to his home in Key West, FL. From time to time, I would run into Eric at BIO meetings and Mickey and I would meet up at my all time favorite Vietnamese restaurant (Hy Vong) in Little Havana in Miami, FL. Eric has since retired after 30 years in the pharma/biotech biz and Mickey unfortunately passed away from cancer in the early 2000s.

 

After meeting Eric and Mickey, I knew that Versicor would be a success one day—the $1.9 billion that Pfizer paid for Vicuron tends to validate that notion. While I didn’t benefit financially from Versicor, I was lucky and fortunate to meet two, really smart, fascinating and genuine individuals who helped me to establish my credibility in the biopharmaceutical industry.  As the saying goes “Money isn’t everything!”

 

Hat tip to Ed at Pharmalot.

 

Until next time…

 

Good Luck and Good Job Hunting!!!!!

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A friend of mine accidentally gashed his leg on an open dishwasher door and thought nothing of it for several weeks until he noticed that the wound wasn’t healing and it hurt really badly. He eventually went to the emergency room at a local, where the ER docs cultured the wound and sent him home with a prescription for oral antibiotics. The antibiotics stopped working several days later and he wound up in another local hospital–this time he was admitted and the spent the next 5 days on a variety of intravenous antibiotics. Despite the treatment (they could not find the right antibiotic combination at first because  they never recultured the wound) his leg turned black from his ankle to his knee and they almost had to amputate. He is back at home now and will be treated with a regimen of iv antibiotics for the next 6 weeks or so. I talked with him last week and I learned that his leg wound is still not completely healed and the infectious disease docs are worried!

My friend almost lost his leg because of a lack of understanding about bacterial infections and antibiotic resistant bacteria and— unfortunately— because of substandard wound care treatment. With this in mind, I am posting what I think are useful tips (from the June issue of the Mayo Clinic Women’s Health Source) about how to prevent, manage and treat wound infections to minimize the emergence and spread of multiple, antibiotic- resistant bacteria.

• Wash your hands: This simple procedure, done properly, remains the best defense. Carry alcohol-based hand sanitizers for times when hand washing isn’t possible.
• Keep personal items personal: Don’t share towels, soap, sheets, razors, clothing or athletic equipment.
• Sanitize linens: If you have a cut or abrasion, wash towels and sheets with hot water and added bleach. Wash gym and athletic clothes after each use.
• Get infections tested: If an infection requires treatment, ask your care provider to take a culture to confirm what bacteria are present before you are given an antibiotic. (Editor’s note: Unfortunately, this is no longer standard practice—most infections are treated empirically which is partly responsible for the increasing frequency of antibiotic resistant bacteria.) If you test positive for a Staphylococcus (Staph) infection, ask that a culture be tested specifically for MRSA in case you need a special antibiotic.
• Use antibiotics appropriately: When you take antibiotics, take all doses even when you start feeling better. Don’t demand antibiotics for viral illnesses; antibiotics don’t work with viruses. Taking too many antibiotics over time could become a detriment because the medication’s effectiveness can be compromised by overuse.
• Use antibacterial products sparingly: Antibacterial soaps and cleaning products probably don’t prevent infections at home and may make these products less effective in hospitals.
• Take precautions in the hospital: Ask all hospital staff and visitors to wash their hands or use an alcohol-based hand sanitizer before touching you. Ask care providers to wipe stethoscopes and other equipment with alcohol. Don’t set food or utensils directly on tables or beds. Make sure that intravenous tubes and catheters are inserted under sterile conditions.

I hope that these tips will help to keep you out of the hospital with potentially life-threatening, antibiotic resistant bacterial wound infections!

Until next time….

Good Luck and Good Job Hunting!!!!!!!!!

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Novartis announced today that it intends to purchase Malvern, PA-based Protez Pharmaceuticals for $400 million. Protez is developing a novel spectrum carbapenem antibiotic that is active against variety drug-resistant Gram positive (most notably MRSA )and Gram negative bacterial pathogens. Its lead compound, PZ-601, is in Phase II human clinical testing. Protez acquired PZ-601 (formerly SMP-216601) in 2005 from Dainippon Sumitomo Pharmaceuticals.   

Novartis is buying Protez to sure up its antibacterial drug pipeline. Novartis already sells Cubicin, (manufactured by Massachusetts-based Cubist Pharmaceuticals Inc.,) in Europe and is developing other antimicrobials including Aurograb and Tifacogin to treat infections.

Like many of the newly marketed antibiotics, PZ-601 is injected and not orally bioavailable. Nevertheless, it is likely that PZ-601 will provide much needed help against the ever increasing number of drug resistant bacterial isolates. Swiss companies Basilea Pharmaceutica AG and Arpida Ltd. are also working on experimental medicines to treat MRSA.

It is not clear how the acquisition will affect Protez employees.  I suspect that most of the employees will keep their jobs except for Company officers.

Until next time…

Good Luck and Good Job Hunting!!!!!

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There has recently been an inordinate amount of press coverage about methicillin-resistant Staphylococcus aureus (MRSA) or “MERSA” as it is called on my local nightly news. As a card-carrying microbiologist, I think that it is great that the American public is finally learning about multidrug resistant bacteria and the serious public health threat that these bacteria pose. For those of you who don’t know, the incidence of MRSA (and other multidrug resistant bacteria) has been steadily rising since the early 1990s –mostly in healthcare and hospital settings (not in the general population). Not surprisingly, the recent media focus on MRSA has resulted in a lot of misinformation about MRSA strains. For example, every MRSA news clip that I have seen in past week has a school janitor in a mask, gloves and laboratory coat feverishly washing walls, desks (and even toilets) at the schools where MRSA-infected students and staff have identified. I can’t help but chuckle (after I get righteously indignant) when I see these clips because S. aureus (whether it is methicillin resistant or not) is an opportunistic pathogen that is transiently carried in the nasal passages of over 50% of all Americans! Contrary to popular belief, S. aureus does not survive for long periods outside of the human body. That said, school janitors can scrub as much as they want but they will not eliminate the natural reservoir of the organism which is the students and staff who work at the schools! Further, the organism, although infectious, is not easily transmitted from person to person–it requires direct and intimate personal contact in order for that to occur. Also, just because the organism is resistant to methicillin it doesn’t mean that there are no other antibiotics that can be used to treat MRSA infections. In fact, if diagnosed early and correctly, MRSA infections are easily treated. So, why is the news media making such a big deal about MRSA? As far as I can ascertain, people who die from bacterial infections is big news because people ARE NOT suppose to die from infections in modern medical practice. There is nothing inherently more diabolical about MRSA than other strains of S. aureus except that they are methicillin resistant. In other words, MRSA strains are not more infectious nor do they cause more serious disease than non-MRSA isolates. That said, what is noteworthy about the majority of people who have died from MRSA infections is that most of them either had limited or no access to adequate medical care. People with S. aureus infections who do not seek treatment in a timely fashion or are misdiagnosed by a poorly trained emergency room physician increase their risk of serious illness (or even death) whether the organism is MRSA or your run-of-mill S. aureus isolate. The point that I am trying to make is that MRSA strains have been around for almost a generation–what has changed is that millions of Americans no longer have access to adequate healthcare. Until we improve access to healthcare for ALL Americans, I suspect that millions more will die from otherwise treatable bacterial infections.

Until next time…

Good Luck and Good Job Hunting!!!!!!!!!!!!

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