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The recent E. coli 0104:H4 outbreak of gastroenteritis in Europe that sickened thousands and killed over 20 people was one of the largest foodborne disease outbreaks in the world (for the latest updates check out this article). This prompted my colleagues over at Onlinecertificateprograms.org to post an article entitled “10 Worst Food Contamination Outbreaks” that outlines the most serious foodborne illness to afflict the US.

Some of you may remember some of the more highly publicized ones including the “Jack in the Box” and “Sizzler” E. coli outbreaks in 1993 and 2000 respectively. While E. coli is still on everyone’s mind, the other usual suspects including Salmonella, Listeria and botulism are also featured!

 Here is the list! 

1. Washington Packing Corporation, Botulism (1963): After two women died from botulism due to eating a bad can of A&P tuna packed by the Washington Packing Corporation, health authorities began investigating the company's foods, eventually discovering that the bad tuna had been shipped and stocked in major population centers throughout the Midwest. Wary consumers immediately stopped purchasing tuna, causing the then $277 million industry to suffer a 35% decrease in sales. The families of the two women were paid $226,500 by Washington, which was shut down after the incident.
2. Skewer Inn Restaurant, Botulism (1983): Botulism struck again 20 years after Washington, resulting in one death. The oversight occurred at Peoria, Illinois' Skewer Inn, a popular restaurant located in the constantly-busy Northwoods Mall. Each victim ate beef patty-melts containing contaminated onions, later experiencing symptoms such as blurred vision, slurred speech, trouble breathing and paralysis. Overall, 28 people were hospitalized, 12 of whom required ventilatory support for varying periods of time.
3. Jalisco Cheese, Listeria (1985): The deadliest food contamination outbreak in US history was caused by listeria, a bacteria found in sewage, soil, stream water and plants that manifests through fever, aches and diarrhea. Many of the 142 Southern Californians who fell ill from Jalisco's Mexican-style soft cheese suffered dire consequences — 48 died including 19 stillbirths and 10 infants. When an investigation was completed, the bacteria were traced back to poorly pasteurized milk used to make the cheese at an Artesia plant.
4. Hillfarm Dairy, Salmonella (1985): Consumers would've been best-advised to avoid dairy products altogether in 1985. The Hillfarm Dairy debacle wasn't as severe as the Jalisco debacle, but it was far more widespread, as 16,284 cases of food poisoning due to salmonella were confirmed and possibly 200,000 cases altogether existed in the Midwest. Two deaths resulted, and as many as 12 may have occurred due to two batches of tainted milk produced in Melrose Park, Ill.
5. Jack in the Box, E. coli (1993): Highly publicized and nearly catastrophic for Jack in the Box, the 1993 E. coli outbreak in the Pacific Northwest could've been prevented if the fast food chain had selected better meat, or at least cooked the contaminated meat at the right temperature. According to reports at the time, the patties eaten by the victims contained fecal matter and weren't cooked at 155 degrees Fahrenheit as mandated by Washington state law. Four children died and more than 700 others became sick, prompting the USDA to enforce stricter regulations, and Jack in the Box to overhaul its food safety procedures.
6. Sizzler, E. coli (2000): One of the nation's largest steakhouse franchises experienced a crisis in 2000 when an E. coli O157:H7 outbreak in Milwaukee, Wis., originating from two restaurants in the area, sickened 65 people and killed a three-year-old girl. Health officials discovered that raw meat shipped from the Excel meat packing facility in Colorado came into contact with food eaten by the victims. According to Sizzler, it required all of its restaurants to cook beef entrees at the 160-degree temperature recommended by the US Food and Drug Administration.
7. Pilgrim's Pride, Listeria (2002): At the time, it spurred the largest meat recall in US history. The listeria outbreak of fall 2002 ended with 46 illnesses, three miscarriages and the deaths of seven people, causing Pilgrim's Pride, then the second-largest poultry company in the US, to suspend operations at its Franconia, Pa. plant. From there, products were shipped to grocery stores, food service institutions and restaurants around the country, specifically affecting Connecticut, Delaware, Maryland, Michigan, New Jersey, New York, Ohio and Pennsylvania.
8. Chi-Chi's restaurant, Hepatitis A (2003): Typically a problem suffered by residents of developing countries where personal hygiene standards are poor, a hepatitis A outbreak is a problem most Americans don't worry about facing. Thanks to a batch of green onions used in food at Chi-Chi's Mexican restaurant in Beaver, Pa., more than 660 people fell ill and four people died in the nation's worst outbreak of the infectious disease. Almost all of the victims contracted it by eating mild salsa and cheese dip, which contained raw onions that were traced to Mexico.
9. Natural Selection Foods, E. coli (2006): Veggie eaters across America halted their consumption of spinach in late 2006, as reports surfaced that certain helpings were contaminated with E. coli O157:H7. In early fall, 199 people were infected in 26 states — 31 of whom suffered kidney failure — and three people died. At fault was a farm in San Benito County, Calif., where CDC investigators suspected irrigation that was possibly contaminated from cattle feces, originating from nearby Paicines Ranch, came into contact with spinach fields.
10. Peppers and Tomatoes, Salmonellosis (2008): Jalapeno peppers, serrano peppers and tomatoes contributed to the 2008 United States salmonellosis outbreak, which proved difficult for the CDC to trace. Ultimately, investigators discovered the strain in irrigation water and serrano peppers originating from a packing facility in Nuevo Leon, Mexico and grower in Tamaulipas, Mexico. It infected 1,442 people in 42 states, with the most incidences occurring in Texas (384). At least one death was attributed to the outbreak.

Until next time...

 Good Luck and Good Eating!!!!!!!!

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The Centers for Disease Control (CDC) in Atlanta, GA estimates that there are about 48 million illnesses caused by food borne bacteria each year. As many of you know, the incidence of outbreaks of Salmonella gastroenteritis is growing steadily and it seems that a week can’t go by without a report of a new outbreak. For those of you who are so inclined, the CDC publishes a weekly report entitled Morbidity and Mortality which tracks and reports the incidence of infectious diseases in the US. 

Interestingly, most food borne disease outbreaks primarily result from improperly handling, storing, transporting or preparing of raw food stuffs and consequently are easily preventable. To that end, the folks at Nursing Schools.net sent me a link to a post on their website that describes ways in which to better manage raw foods that can help to prevent or minimize the incidence of food borne illnesses in the US. An excerpt of the post is shown below.

The 12 Most Common Causes of Food Poisoning

**It is important to point out that the term “food poisoning” is anachronistic because in the past, it was not clear what was responsible for the illnesses caused by tainted food. While not currently used much in food microbiology circles, food poisoning (or intoxication) was historically used to describe ingestion of food that contained bacterial toxins but no living bacteria and caused disease. Staphylococcal “food poisoning” is the most common type of food intoxication that causes disease. In contrast, food borne illness is used to describe disease caused by ingestion of contaminated food containing live bacteria which subsequently colonize the lower gastrointestinal tract, invade the intestinal mucosa and thereby cause disease.**

Raw or undercooked food. Whether you're cooking at home or going out, eating food that hasn't been cooked thoroughly or brought to the appropriate temperature can put you at high risk of developing food poisoning. While you might enjoy rare steak, runny eggs or certain raw veggies, these foods can all carry bacteria when they are not cooked long enough or hot enough to kill off the offending particles. Common bacteria found in undercooked food include Escherichia coli, Salmonella and Campylobacter. Be safe instead of sorry and ask that your food be cooked through or use this chart when at home.

Food that is not stored at the proper temperature. While simple common sense would tell you that leaving foods like meat and dairy products out of refrigeration makes them unfit to eat, temperature regulation can be a bit more complicated. Refrigerators can malfunction, foods can be forgotten on the counter and instructions on labels can be misread. To keep yourself safe, always check the temperature on your fridge and freezer. They should be at 40 degrees F and zero (0) degrees F respectively. Always read the label to see what foods will need be refrigerated immediately and which have to be cooled after opening. If you plan to freeze foods, do it within 2 days of purchase. This can help prevent some very serious bacteria from growing and making you sick.

Letting food sit out. Most of us are smart enough to not let refrigerated foods sit out, but sometimes we can forget to put away the leftovers or want it on hand at a party. In order to keep these foods safe to eat and avoid some common bacteria taking hold, you should always put leftovers away as soon as you can. If you're serving food at a party, keep hot food at 140 degrees F or warmer, cold foods at 40 degrees F. Never leave perishable food out for more than two hours, especially if the weather is warm. This will help ensure that neither you nor your guests end up sick.

Not washing hands before eating or preparing food. Contamination of foods from dirty hands is a big cause of many cases of food poisoning. Always wash your hands thoroughly before and after handling foods at home (for at least 20 seconds) and only eat at restaurants with strong showings in health department assessments. Additionally, always make sure your hands are clean before eating food as well, especially if you will be touching them. Without these precautions, you could put yourself at risk of coming in contact with bacteria like staphylococcus-aureus and Clostridium perfringens.

Contamination of other foods by raw meat. Cross-contamination of foods is a major health issue and one that many out there should be highly conscious of avoiding at home. When juices from contaminated meat get onto cutting boards, hands and into the refrigerator, contamination can spread to other foods, some of which you might not plan to cook at all. It is essential to keep raw meat, poultry and fish separate from other foods. Always wash any utensils, countertops and cutting boards that have come in contact with them immediately, sanitizing them with bleach and water, or even having separate tools for handling meat can be a big help.

Eating raw shellfish. Raw oysters may be a delicacy, but ingesting them doesn't come without some serious risks. Oysters from the Gulf of Mexico are commonly contaminated with Vibrio vulnificus bacteria which can cause mild to serious food poisoning. Additionally, even oysters that do not come from this region are often left un-refrigerated for several hours while being brought to shore. While you may be fine after eating raw oysters, be aware that ingestion of these shellfish uncooked is a big risk and could lead to serious health issues.

Improper canning. Canning foods at home has been a common practice for several decades, but it's one that needs to be carefully monitored in order to ensure that the food being preserved won't carry contaminates along with it. Botulism is perhaps the most common bacteria contaminant in improperly canned food, and is one of the most serious and potentially deadly forms of food poisoning out there. Always boil jars and lids to be used in canning to kill off any lingering bacteria and make sure that all cans are properly sealed. Improper canning can also happen with foods you get off grocery store shelves so look out for bulges, discolored food, or seepage.

Ingesting expired food. We've all done it at one point or another, but eating expired food comes with a big risk for food poisoning attached. Always check expiration dates before ingesting any food in your home or purchased at the store. If there is no date on the package, no packaging or only a sell by date, use the government guidelines for cold storage to help you determine if a food is safe to eat or not.

Not heating or reheating thoroughly. You might think that you only have to worry about food poisoning in foods that haven't already been cooked, but that's not entirely the case. You should also be careful with foods that you're reheating, especially if they've been hanging out in your fridge for more than a couple of days. When reheating foods, make sure that meats reach a temp of at least 160-170 degrees F and that other foods come to around 165 degrees F. This will ensure that any bacteria that might have made its way into the food will be killed off and that you'll be able to avoid a common cause of food poisoning.

Not washing produce thoroughly before preparation. Even those seemingly innocuous veggies can be the source of food poisoning if not washed and prepared properly. Prior to reaching your table, there's no telling how many things they may have come in contact with, so always clean any fruit or vegetables with a soft kitchen brush and water (or a pre-prepared veggie wash) to ensure that any bacteria it contains will be largely washed away. This is especially important with foods that you do not plan to cook. While foodborne illness is more commonly caused by meats, recent outbreaks of Salmonella and E. coli have originated in spinach and tomatoes.

Unclean cooking utensils and surfaces. When it comes to food safety, cleanliness matters. Dirty kitchens attract mice and rats that can spread disease and also create ideal places for bacteria to grow and thrive and access your food. It's essential to keep any space you plan to cook in and any tools you plan to use highly sanitized. The USDA advises putting a tablespoon of bleach into one gallon of water to create a sanitizing liquid. This can help prevent any bacteria hanging out in your kitchen from getting on food and will ensure that none are able to cross contaminate one another.

Unpasteurized foods. For the most part, people are fine after eating foods that are unpasteurized, provided they have been stored and served in a safe manner. Yet for those with compromised immune systems, who are pregnant and the very young and very old could be at risk for food poisoning from these. Commonly pasteurized foods include milk, cheeses, yogurt, ice cream, ciders and juices. Unpasteurized versions of these foods can carry Salmonella, E coli, and Listeria monocytogenes, which can make individuals very sick

While these precautionary and preventative tactics will help to reduce food borne illnesses, it will not eliminate them completely. But, it is a good place to start to improve food safety and public health!

Until next time...

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

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According to a "mention" today on the Pharmalot blog, a French newspaper reportedly learned that Sanofi-Aventis may be spending up to $1 billion this year to acquire up to four ophthalmology companies. Although the companies were not identified, three of the companies that Sanofi is eying (pun intended) are located in the US and the fourth is reportedly in Israel.

An aging global population coupled with the diabetes epidemic plaguing the US and several other Western countries suggest that ophthalmology drugs may be a good bet for the future. This, coupled with the impending acquisition of Genzyme suggests that Sanofi-Aventis is trying to create somewhat of a soft landing for the company after patent expiry in early 2012 of Plavix, its major money maker.

Until next time...

Good Luck and Good Job Hunting!!!!!

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The era of blockbuster drugs was officially declared over several years ago by many pharmaceutical analysts and pundits. Nevertheless, as the old adage goes “it’s difficult to treat old dogs’ new tricks!” After all, the blockbuster drug model has been the major driver of pharmaceutical and biotechnology markets for close to 50 years. Consequently, big pharma and biotech companies haven’t truly abandoned the possibility of finding potential new blockbusters. And, it appears that the blockbuster heir apparent may be drugs to treat rare aka orphan disease indications. 

At first blush, this strategy may not make a lot of sense. This is because rare diseases afflict only small numbers of patients (at least in the US and other Western nations). However, what may be considered a rare disease in Europe or the US may actually be less rare in countries with large populations like China and India. Further, while current rare diseases patient populations may be small, the cost of the drugs developed to treat them is extremely high. In some instances, the annual cost per patient can exceed several hundred thousand dollars. If you do the math, it becomes apparent that developing rare disease treatments or so-called niche busters can actually be very big business. 

The rare diseases business model has been perfected by Genzyme and many big pharma companies are trying to emulate it. To that end, big pharma’s push into rare diseases continues to gather momentum. So far this year Sanofi-Aventis has made an $18.5bn move for Genzyme, while Pfizer and GlaxoSmithKline have both created rare disease business units.

According to Glaxo’s estimates, 7,000 rare diseases have been identified and collectively this affects 6-8% of the world’s population; in the US and Europe alone rare diseases affect 25 million people. In addition mortality rates are very high, often at a very young age, and less than 10% of these diseases are treated with approved drugs.

To date, over 7,000 rare diseases have been identified. Companies involved in the new rare diseases treatment race have whittled the list down to roughly 200-250 disorders that represent a clear path for clinical, regulatory and commercial success. The criteria used to select these indications include identifying rare disorders with: 1) a relatively high prevalence rate, 20 an early age of onset, 3) a large unmet medical need and 3) a known molecular target. The indications have been broadly classified into four distinct groups:  metabolic disorders, autoimmune/inflammation, central nervous system and blood disorders.

While Genzyme identified, developed and commercialized its rare diseases treatments, it is likely that big pharma companies like Pfizer, Glaxo, and Merck will either in-license potential new treatments or acquire companies with platform technologies or drugs in various stages of clinical development. For example, Merck’s acquisition of Glycofi several years ago has allowed the company to enter into the rare diseases and biosimilar markets.

One of the major problems with extant rare diseases treatment is their excessive and oppressive costs. One can only hope that the increased competition in the rare diseases space will help to lower drug prices and make them more affordable for patients who suffer from these devastating and life-threatening disorders.

For more insights in to the orphan drug disease market, check out an article that I wrote for Life Science Leader this month

Until next time...

Good Luck and Good Job Hunting!!!!!

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There was an extremely troubling article in today’s New Jersey Trenton Times that indicated that a New Jersey’s childhood vaccination rates ranked 42nd in 2009—45^th in 2008—in the nation. The ranking were based on annual vaccination statistic compiled by the Centers for Disease Control in Atlanta, GA.

The lead-in paragraph to the article elegantly captured the irony of the dubious statistic:

“One of the most affluent (and most populous states) states in the country, home to more than a few giants in the pharmaceutical industry also has one of the lowest rates of immunizing babies and toddlers in the nation.”

New Jersey’s vaccination rates among infants and toddlers for childhood diseases— mumps, measles, diphtheria, Pertussis (whooping cough), hepatitis B and rubella—was roughly 64 percent in 2009. This was significantly lower than the national average of 71 percent and the lowest in the Northeast. For example, in Pennsylvania and New York, two of the states bordering New Jersey, the vaccination rates in 2009 were 72 and 71 present respectively.

The reasons given for the low rate are plausible but, in most cases, incomprehensible from an infectious diseases and public health perspectives. It has been postulated that low-income and immigrant communities lack health insurance and access to medical information about mandatory childhood vaccination regimens. While it is facile to blame low income and immigrant populations for New Jersey's  egregiously low vaccination rate, the problem may actually lie with more affluent and educated NJ citizens who have medical insurance (help to pay the salaries of medical billing workers) and understand the public health implications of mandatory childhood immunizations. 

According to the article, parents and even some health care professionals are backing away from mandatory vaccination because they “don’t like seeing kids cry” after sometimes receiving up to four vaccinations during a single office visit! Say what????? I accompanied my three children for most of their childhood immunizations, and while some tears may have been shed, they recovered quickly and are now protected against a variety of potentially life-threatening diseases.  Apparently, some parents and health care professionals are willing to jeopardize the public health of a nation because the “shots hurt.” To that I say; get over it—like it or not, life can be painful and no matter how hard you may try you cannot shield your kids from it!

The fallacious and recently publicly discredited link between childhood vaccination and autism, coupled with the growing public distrust of the pharmaceutical companies that manufacture the vaccines may be more plausible explanations for New Jersey’s declining immunization rates in NJ. This suggests that vaccine manufacturers and public health officials ought to work closely together to be educate the American public about the benefits and potential risks associated with childhood vaccination.

Finally, as some of you may know, many states like New Jersey have religious exemptions that allow children to skip mandatory childhood immunizations. Interestingly and troublingly these children are allowed to attend public schools despite the fact that they haven’t been vaccinated. Again, I say what??? Increasingly, these unvaccinated students have been implicated as the reservoirs for the pertussis outbreaks that are currently ravaging school aged children and older adults throughout the US. It is my belief that children who fail to receive the appropriate immunizations because of religious reason should not be allowed to attend public school. This is because, unlike many of the low income and immigrant families who may be unaware or cannot afford to immunize their children because they lack health insurance, many of the folks claiming religious exemptions have health insurance and are living above the poverty level. Consequently, if these parents choose to not immunize their children (and fail to meet mandated public health requirements for entry into public schools), then they ought to be financially responsible for their child’s education.

Paradoxically, the plummeting vaccination rates in New Jersey and elsewhere are being driven by a small but extremely vocal segment of the American public. Unfortunately, this anti-vaccine sentiment in America is unlikely to abate until an increasing number of children begin to die from easily preventable childhood diseases. As far as I am concerned, the benefits of childhood vaccines far outweigh their risks and help to maintain the public health of all Americans.

Until next time...

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

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The New York Times reported today that French drug maker Sanofi Aventis has made a bid to purchase beleaguered orphan drug manufacturer Genzyme. According to the report, Sanofi approached Genzyme about two weeks ago about a possible sale. Sanofi is currently waiting for a response from Genzyme. If Genzyme rebuffs the takeover bid, persons close to the deal said that Sanofi may possibly try to acquire Genzyme via a hostile takeover bid.

Sanofi is facing revenue losses because many of its blockbuster products including the anti-clotting agents Plavix and Lovenox will or have lost patent protection. Plavix's patent expiry will occur in 2001 whereas Lovenox has already lost patent protection ( yesterday the FDA approved a generic version of the drug). Further, Sanofi, unlike most major pharmaceutical companies, is glaringly deficient in biotechnology products and has long been known to be seeking a quick entry into the biotech market. To that end, the Genzyme bid makes complete strategic sense to bolster sales and secure Sanofi's future.

Genzyme is the fifth largest biotechnology company in the world. Sales of it orphan drugs to treat Gaucher’s, Fabry and Pompe disease annually exceed $3.0 billion in sales even though they are used to treat small numbers of patients (<20,000).

Genzyme’s value has plummeted in the past year because of manufacturing problems and is currently operating under a US Food and Drug Administration consent decree after being fined $175 million by the agency. Many shareholders have called for the dismissal of Henri Termeer, Genzyme’s CEO for the past 25 years. To date, Termeer has refused to step down even though Genzyme’s stock continues to under perform. News of a possible takeover caused Genzyme’s stock price to soar; gaining more than 15 per cent on Friday to $62.50.

I believe that Sanofi is approaching Genzyme at the right time. Recently, Genzyme reached an agreement with Carl Icahn, who owns a substantially amount of stock, to prevent a proxy battle to reshape Genzyme’s board and oust Termeer. Also, another major shareholder, Ralph Whitworth, is unhappy with recent events at the company. Sanofi’s acquisition of Genzyme would provide a quick entry into the biotechnology and orphan drug markets and also appease shareholders like Icahn and Whitworth if the deal is rich enough. Also, Sanofi’s manufacturing experience would help Genzyme overcome its problems in that area.

Stay tuned for updates.

Until next time...

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

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Pfizer today announced plans to set up a Rare Diseases Research Unit that will target the more-than-6000 global orphan diseases. For those of you who may not know, orphan diseases are classified by the US Food and Drug Administration as those that afflict 200,000 persons or less.

According to a press release, Pfizer’s new division will “pursue treatments across all therapeutic areas and modalities and will serve as the focal point for the company’s existing research on rare diseases”. It also intends to “work closely with patient advocacy groups, like the National Organization for Rare Diseases, as it develops and advances the unit’s research strategy. It will be lead by Edward Mascioli, most recently the head of Dapis Capital, a private equity firm. Previously he was vice president of clinical affairs at Peptimmune and senior medical director at Paraxel.

Pfizer’s decision to enter the orphan drug market signals that no markets are too small for big pharmaceutical companies to consider in an era where blockbuster drugs are few and far between. Nevertheless, it is noteworthy that orphan drugs (which are generally biologics) offer drug maker several perks including: seven years of market exclusivity, tax breaks and credits, reduced clinical trials costs and expedited regulatory review. More importantly, perhaps, orphan drugs are highly priced and can yield impressive returns even though they are used to treat small patient populations. For example, several of Genzyme’s drugs such as Myozyme and Cerezyme—both designated as orphan drugs—have already reached over $1.0 billion in annual sales. 

While sales of orphan drugs may never reach those of Plavix, Lipitor, Epogen and other multibillion dollar blockbusters, garnering US regulatory approval for four or more (which cost much less than $1.5 billion to develop) will likely provide a substantial ROI to companies that develop them. Also, developing drugs that improve the quality of life for patients with no other treatment options will undoubtedly go a long way to improve tarnished reputation of the pharmaceutical industry.

Until next time...

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

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The recent manufacturing woes of orphan drug manufacturer Genzyme have been well documented and widely publicized. These problems resulted in massive shortages of some of its top selling drugs Cerezyme (Gaucher disease) and Fabrazyme (Fabry disease) causing many of the patients who depend on these drugs to maintain their quality of life to go without reduced or no treatments for months. 

Because both drugs were approved by the US Food and Drug Administration (FDA) as orphan drugs they enjoy seven years of market exclusivity from the date of regulatory approval which prohibits other companies from seeking approval and selling similar drugs in the US. Consequently, Genzyme is the only commercially-available source for the drugs. Genzyme’s ongoing biomanufacturing created massive shortages of both drugs last summer. Because of this, FDA allowed two other companies, Shire and Protolix Biotherapeutics (both have treatments for Gaucher (Protalix) and Fabry (Shire) disease in late stage clinical development), to make their drugs available (at no charge) to patients prior to regulatory approval. This was a relatively rare and bold move by the agency. But, to be fair, they had little choice because so many patients were suffering.  

In case you may be wondering there are approximately 1500 Cerezyme users and fewer than 1000 Fabrazyme users in the US. Despite the small numbers of patients, the cost of the treatments are extraordinarily high; costing patients as much as $200,000 per year for treatment.

According to an article in today’s NY Times as many a 15 percent of American Cerezyme users have switched to a different drug. Fewer patients with Fabry disease have switched mostly because Shire’s drug for Fabry disease Replagal was less widely available. The almost year-long shortages of both drugs have seriously tarnished Genzyme’s reputation. And previously loyal patients are questioning their almost decade long allegiance to the company. This, coupled with a 26 per cent decline in Genzyme’s stock price last year suggest that Genzyme’s standing as one of the top five biotechnology companies in the world may be in serious jeopardy. 

Despite calls for his resignation (and an attempt by Carl Icahn to wrest control of the company), CEO Henri A. Termeer, who has led Genzyme for over 20 years has vowed not to resign. While manufacturing problems are not uncommon in the biotechnology industry, the severity and ongoing nature of the manufacturing problems at Genzyme’s Allston Landing, MA production facility are unacceptable; especially for a company that specializes and prides itself in developing treatment for orphan disease indications. The FDA recently announced that it would fine Genzyme and place its manufacturing operations under a consent degree for an indefinite period of time.

Genzyme representatives now contend full supplies of Cerezyme will be available after May 1 and those for Fabrazyme possible in the third quarter of this year.

While so-called “copycat” or “me too” drugs developed by pharmaceutical companies tend to be vilified by consumers and patient advocacy groups, the agency prefers to approve more than one treatment option for a given disease indication in case one medication doesn’t deliver the intended therapeutic benefits or induces untoward adverse events. Unfortunately, the seven years of market exclusivity awarded to orphan drugs manufacturers that garner regulatory approval for their products prohibits this. The biomanufacturing fiasco at Genzyme suggests that it may be time to reexamine the Orphan Drug Act and modify some of the financial and regulatory terms that were included to induce drug companies to develop new treatments for orphan disease indications.

Until next time…

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

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Virologist and BioCrowd co-founder Vincent Racaniello, PhD recently gave a talk at the Spring 2010 meeting of the Society for General Microbiology in Edinburgh, Scotland.

The talk, entitled ‘Social Media in Microbiology Education and Research’ reviewed how Professor Racaniello uses blogging, podcasting, and other social media tools to teach the public about viruses.

To learn more about Vincent and how he uses social media to increase the publics’ awareness about viruses and other infectious agents, please visit the BioCrowd website.

Until next time…

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

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Orphan drug manufacturer Genzyme today issued a press release that the US Food and Drug Administration (FDA) notified the company that it intends to take enforcement action to ensure that products manufactured at its troubled biomanufacturing facility in Allston Landing, MA are made in compliance with good manufacturing practice regulations.

The agency’s enforcement action will likely result in a consent decree under which a third party would inspect and review the plant’s operation for an extended period and certify compliance with FDA regulations. Under a consent decree, Genzyme also would be required to make payments to the government and could incur other costs.

The Allston Landing facility was experiencing product quality problems for some time before FDA intervened and threatened regulatory action and sanctions against the orphan drug producer. According to the press release Genzyme will:

work cooperatively with the FDA to restore the agency’s confidence in its ability to operate the Allston plant at the highest standards, building on the progress it has made over the past year to address the manufacturing deficiencies at the Allston plant. This progress includes:

• Retaining a leading quality assurance advisory firm to help develop a comprehensive strategy and risk mitigation plan. More than 30 expert consultants from this firm are currently working at the Allston plant or at other Genzyme manufacturing facilities.
• Naming a new site head and reorganizing and strengthening the management team at the facility.
• Hiring two highly regarded industry veterans to serve as President of Global Manufacturing and Corporate Operations and Senior Vice President of Global Product Quality.

While this is not good news for Genzyme, it is great news for patients who rely on Genzyme’s medicines to manage their oft times devastating and potentially life threatening genetically-inherited diseases.

Until next time…

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Genzyme announced in a Securities and Exchange Commission filing on Monday that it inked a "fill and finish manufacturing services" deal with Hospira for several of its top selling drugs including Cerezyme (Gaucher disease), Fabrazyme (Fabry disease, Myozyme (Pompe disease) and Thyrogen (thryroid cancer). The move follows a series of highly publicized manufacturing problems at the company’s Allston Landing, MA biomanufacturing facility in 2009.

Beginning in March, Genzyme received a warning letter from the US Food and Drug Administration (FDA) detailing "significant objectionable conditions" at the Allston facility. The agency identified deviation and violations of current Good Manufacturing Practice (GMP) in four areas including: 1) maintenance of equipment, 2) computerized systems, 3) production controls and 4) the failure to follow procedures aimed at preventing microbiological contamination.

In June, Genzyme shut down the biomanufacturing plant to clean up viral contamination that had been slowing down production of Cerezyme and Fabrazyme. The virus, Vesivirus 2117, is known to interfere with the growth of Chinese hamster ovary (CHO) cells and is believed to have been introduced through a cell culture nutrient. The virus doesn’t infect humans, but the shutdown cost the company millions in revenue and caused shortages of Cerezyme and Fabrazyme. Production restarted at the plant in September.

Meanwhile, in November, the Food and Drug Administration said it found tiny particles of steel, rubber and fiber in finished vials of Cerezyme, Fabrazyme, Myozyme, Aldurazyme (mucopolysaccharidosis I) and Thyrogen. These and other violations are outlined in a 483 that was issued by FDA following inspection of the troubled facility.

The deal with Hospira, which makes drug and medication delivery systems,calls for the initial term to expire on Dec. 31, 2015. There are options for a two-year extension. The financial terms of the agreement were not disclosed. The deal is still subject to regulatory approval for manufacturing the products.

While GMP deviations and warning letters are common place at many biotechnology companies, Genzyme’s ongoing manufacturing problems had potentially grave medical implications. This is because, unlike most of its competitors, Genzyme focuses almost exclusively on the development of orphan drugs. Orphan drugs are used to treat diseases like Gaucher, Fabry and Pompe disease which are rare, afflict relatively small numbers of patient and usually result from genetic mutations. Generally speaking, there is usually only a single manufacturer of orphan drugs. Consequently, manufacturing problems can result in drug shortages which may inhibit access to these life saving drugs. As corny as it may sound, patients with orphan diseases have literally placed their lives in the hands of the drug companies that manufacture these orphan drugs.

Until last year, Genzyme had an outstanding and impeccable reputation and was regularly lauded by the orphan drug community. Unfortunately, its management team lost sight of its original to commitment to quality—a sign that changes may be necessary in the executive suite. Hopefully, the new fill and finish deal with Hospira will eliminate many of the company’s manufacturing problems and Genzyme can restore confidence in its brand!

Until next time....

Good Luck and Good Manufacturing !!!

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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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As we all know, the H1NI pandemic has been raging on for close too 10 ten days now. Curiously, “Fear & The Flu: The New Age of Pandemics” is the title this week’s cover story in Newsweek magazine. From an informational standpoint point, “this may be too little, too late”—as the old saying goes. While the Internet has been around for over twenty years now, government agencies, most notably the US Food and Drug Administration (FDA) and the Centers for Disease Control (CDC) continue to rely almost exclusively on old media to communicate with the American public during infectious disease outbreaks. Apparently, the administrators who run these government agencies haven’t been listening closely enough to President Obama’s assertion that “we live in the digital age.”

Communications between the public and government health officials is vital when trying to manage and control infectious disease outbreaks. “Every single government agency as well as companies and non-profits need to be digitally literate and competent in a time of pandemic” asserts Eye on FDA blogger Mark Senak. For their performances in recent infectious disease outbreaks, Mark gives CDC an “A” for effort—although there is substantial room for improvement. FDA on the other hand didn’t fair as well. “The FDA is not nearly as sophisticated in terms of digital. Their only Twitter account is for food recalls.  And their YouTube channels are all confusing and unorganized. They have a long way to go.”

The Internet was originally designed as a digital tool to transmit and move large amounts of information from one place to another. That said, it is also a powerful communication vehicle that can be used to broadcast valuable, scientifically-accurate information during infectious disease outbreaks by leveraging social media tools like Twitter, Facebook and instant messaging. To that end, it’s time for public health agencies to recognize the power of digital media and craft communication plans that can be implemented in the next infectious disease outbreak.

Until next time...

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

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A quick perusal of the media coverage of the swine flu outbreak of 2009 would lead many to conclude that this outbreak has the potential to rival or surpass the 1918 flu pandemic—widely regarded as the worst influenza outbreak in history. While the emergence of a new H1N1 swine flu variant is significant note worthy— and has possible public health implications— the unrelenting, often scientifically-inaccurate media coverage did little to quell the fear and anxiety of many Americans.  Once again, the media—rather than physicians, public health officials and influenza experts—“got out in front of the story” and managed to create enough panic, fear and anxiety, the likes of which haven't been seen since the 2003 SARS pandemic. It wasn't until last Friday, when the Wall Street Journal published an interview with Dr. Peter Palese—a leading scientific expert on influenza A infections— did a clearer picture emerge about the severity and public health implications of the current swine flu pandemic.

According to Dr. Palese, there are several reasons why people and public health officials ought to be optimistic about the current pandemic:

• In 1976 there was a an outbreak of an H1N1 swine virus in Fort Dix, New Jersey, which showed human to human transmission but did not go on to become a highly virulent pandemic strain
• The presently circulating swine virus is most likely not more virulent than the other seasonal strains we have experienced over the last several years
• The current swine virus lacks an important molecular signature (the protein PB1-F2) which was present in the 1918 virus and in the highly lethal H5N1 chicken viruses.  If this virulence marker is necessary for an influenza virus to become highly pathogenic in humans or in chickens, then the current swine virus doesn’t have what it takes to become a major killer
• Since people have been exposed to H1N1 viruses over many decades, we likely have some cross-reactive immunity against the swine H1N1 virus. While it may not be sufficient to prevent becoming ill, it may very well dampen the impact of the virus on mortality.  I would postulate that by virtue of this “herd immunity” even a 1918-like H1N1 virus could never have the horrific effect it had in the past.  The most likely outcome is that the current swine virus will become another (fourth) strain of regular seasonal influenza

The landscape of vaccines and anti-influenza drugs has dramatically improved over what it was just a few years ago. Based on what we know of the structure and sequence of the swine virus, these FDA-approved drugs and FDA-licensed vaccines (modified to include the swine strain) would be highly effective against this new virus.  Also, present technologies as well as manufacturing capacities will allow us to make sufficient quantities of a swine virus vaccine for the winter 2009-10 influenza season in the US.

In other words, there is reason for concern but no need to panic beyond typical public health precautions that are taken during “normal” influenza outbreaks.

Dr. Vincent Racaniello, a viral disease expert who writes the Virology Blog, reported that as of Monday there have been laboratory confirmed cases of H1N1 infections in 30 US states with a total of 226 cases and one death in Texas. Globally, 20 countries had reported 985 cases of infection. The highest numbers are in Mexico, with 590 cases and 25 deaths. While there have been 26 deaths to date, the severity of the infection appears to be waning and person-to-person transmission appears to be low.

Unfortunately, there has been some fallout from the news media’s oft times “over the top” coverage of the pandemic. Many US hospital emergency rooms (most notably in Texas and California) have been overwhelmed and overburdened by visits from people who think they may have swine flu. Also, while some schools and daycare center closures were warranted, others may not have been. Finally, and perhaps most important, it is becoming increasingly apparent that the lay public's understanding of infectious agents and the outbreaks that they cause is grossly deficient and must be improved. 

We live in a world where viral pandemics, food poisoning outbreaks and infections caused by multiple-antibiotic resistant bacteria are becoming commonplace. While vaccines, antivirals and antibiotics can afford some protection against many viral and bacterial disease, the best way to fight infectious diseases is to understand what causes them, how they are spread and what public health measures can be implemented to prevent or control their transmission. Until the world becomes better educated about infectious diseases, we will continue to be overly-dependent on the news media during future outbreaks and epidemics.

Until next time....

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

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Do you lie awake a night overwhelmed by the possibility of another infectious disease outbreak? Well, if you want to get a good night’s sleep, I highly recommend that you take a look at a brief history of American epidemics that was published in this past Sunday’s New York Times. According to the article, history shows that the number of American epidemics has been relatively small. In fact, the author suggests that there were only nine major epidemics in the US since 1892. 

While there were several major outbreaks in the early to mid 1900s (Spanish flu, 1918; smallpox, 1947 and polio, 1952), the US has been relatively unscathed in recent years—with the possible exception of the HIV/AIDS epidemic and possibly the herpes and HPV epidemics. This is because of America’s outstanding infectious diseases surveillance networks, its comprehensive vaccination programs and modern medical and hospital infrastructures.

However, no matter how vigilant we are, there is no way to prevent infectious disease outbreaks unless the pathogens that cause the diseases are eradicated from the planet as was the case for the smallpox virus. That said, the best way to manage infectious disease epidemics is to be prepared for all contingencies.  In my opinion, the recent swine flu outbreak—this was its second appearance, the first taking place in 1976—was a practice run. And I think the world did “pretty, pretty good” as Larry David, my former NYC softball teammate and co-creator of Seinfeld would say!

Until next time...

Good Luck and Good Job Hunting

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According to a report on NPR’s All Things Considered program, the Obama Administration has nominated Margaret Hamburg, MD to head the US Food and Drug Administration. Dr. Hamburg is a former health commissioner in New York City who has worked on issues surrounding infectious diseases and bioterrorism. In New York, she instituted a needle-exchange program to help prevent the spread of HIV. She also set up a program, in which health workers went to tuberculosis patients’ homes to help them manage their drug regimens.

A Harvard Med School graduate, Dr. Hamburg was an assistant secretary of health and human services during the Clinton administration and now works at the Nuclear Threat Initiative, which tries to cut the threat from nuclear, chemical, and biological weapons. She opposes abstinence-based sex education in public schools and has been a critic of the marketing practices of the pharmaceutical industry. Further, Dr. Hamburg is a leading advocate for changes in the nation’s public health policies and infrastructure, from local health departments to the highest levels of government. Finally, after eight years of mismanagement and poor leadership, the agency has somebody at the helm with intelligence, experience and is an advocate for change. 

Kudos to Team Obama!

Until next time...

Good Luck and Good Job Hunting (FDA is hiring)!!!!!

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Vincent Racaniello, my partner at BioCrowd, and I were chatting the other day about how cool it would be to develop a web-based map that was able to track infectious diseases outbreaks in real time. After a spirited chat, we both thought that we were on to something REALLY big. And, as is frequently the case, somebody else also had the very same idea.

For those infectious disease aficionados out there, you must check out the Health Map: A Global Disease Alert Map. The map was developed by Clark Freifeld and John Brownstein and is based on an algorithm that is beyond my comprehension. It is not as robust as the map that Vincent and I envisioned, but it is pretty cool and it works very nicely.

Until next time…

Good Luck and Good Disease Hunting!!!!!!!

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Vincent Racaniello, Professor of Microbiology at the College of Physicians and Surgeons at Columbia University and co-founder of BioCrowd ,has created a weekly series called This Week In Virology (TWiV). Each week Professors  Racaniello and Dickson Despommier (another Columbia virologist) discuss the latest developments and public health concerns for a variety of viral diseases.

The weekly discussions are packaged as podcasts, posted on TWiV and Science Podcasters.org and can be downloaded from iTunes. Dr. Racaniello eventually wants to offer TWiV in a vcast format and use it to inform the public and teach students about viral diseases.

So far, Vincent and Dick have created nine TWIV podcasts. Some of viruses that they have discussed include: HIV, Polio, Lassa fever, Rabies, West Nile Virus and even video game viruses. The podcasts are interesting, informative and a good way to learn something about virology—something that may liven up your daily commute!

Until next time,

Good Luck and Good Job Hunting

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No matter what you may think of Google, you gotta love the brilliance and innovative moxy of the guys who run that company. In today’s New York Times, there was a story about a new web tool called Google Flu Trends. This tool is being evaluated as a new early warning system for fast-spreading flu outbreaks in the US.

Tests of Google Flu Trends, suggest that it may be able to detect regional outbreaks of the flu a week to 10 days before they are reported by the Centers for Disease Control and Prevention (CDC). It works by tracking and quantifying number of Americans who enter search phrases like “flu symptoms” into Google and other search engines. By analyzing these searches as they come in, Google Flu Trends creates graphs and maps of the country that show where the flu is spreading.  For example, in early February the CDC reported that the flu cases had recently spiked in the Mid-Atlantic States. But Google says its search data showed a spike in queries about flu symptoms two weeks before the CDC report was released.

According to public health experts “The CDC reports are slower because they rely on data collected and compiled from thousands of health care providers, labs and other sources. The Google data could help accelerate the response of doctors, hospitals and public health officials to a nasty flu season, reducing the spread of the disease and, potentially, saving lives.” Researchers have long contended that information published on the Web amounts to a form of “collective intelligence” that can be used to spot trends and make predictions.

Google Flu Trends appears to be the first public project that uses the powerful database of a search engine to track a disease. This could be the beginning of a new trend in epidemiology. Google hopes to publish the results of its study in Nature.

Until next time…

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

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As the old saying goes, nobody is indispensable.  On the heels of Friday's report about US unemployment reaching 6.1 per cent, I learned that my contract medical writing position would be ending 4 months sooner than expected.  I worked at the company for 1.5 years and was excepting to finish out a two-year stint.

Of course, given the precarious financial state of the pharmaceutical industry, I had been looking and was able to find several opportunities that may translate into freelance gigs or possible employment. That said, if anybody out there is looking for an experienced medical/science/promotional writer, please feel free to contact me by sending a comment to this post or via e-mail: cmintz@bioinsights.com.

I hope that your luck is better than mine!!!!!

Until next time....

Good Luck and Good Job Hunting (I will be looking too)!!!!!!!!!

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There was an alarming article in today’s New Times which reported that greater numbers of parents are rejecting vaccination for their children. You may ask, “How is this possible. Aren’t childhood vaccinations mandatory?  Well, yes and no. As it turns out, 20 states including California, Texas and Ohio allow some kind of personal belief exemption from otherwise mandatory childhood vaccinations. And, more and more parents are opting out every year. In 1991, less than 1% of children in states with personal belief exemptions went without vaccinations. By 2004, the most recent year for which data are available, the percentages swelled to over 2.5 %. Frighteningly, according to a 2006 article in the Journal of the American Medical Association, exemption rates of 15% to 18% has been found in certain areas of Oregon, Washington and California.

So, what is responsible for this startling increase? Unfortunately, misinformation on the Internet promulgated by American news media outlets has caused some parents to question the safety of many childhood vaccines including those for measles, mumps, rubella, and diphtheria and whooping cough. Although parents who opt to not vaccinate their children believe that they are protecting them from serious vaccine-induced side effects, they are, in reality, increasing the risk that their children and others may contract these diseases. Surprisingly, many parents who choose not to vaccinate their children are aware hat they may be placing other children at risk. For instance, in the NY Times article, one mother chose not to vaccinate her child said, “I cannot deny that my child can put someone else at risk” 

The growing US anti-vaccination movement has caused serious alarm among many infectious disease specialists and public health officials– and with good reason. This year, there was an unusual outbreak of measles in California in which 12 unvaccinated children contracted the disease. In 2005, there was a mumps outbreak in Iowa that infected 239 people (many of whom were vaccinated) and in 2006 there was a measles outbreak in Indiana that affected 28 unvaccinated children. Ironically, the success of the US childhood vaccination program may be its “Achilles heel.” according to some epidemiologists. This is because most American parents, unlike their counterparts in developing countries where childhood disease like measles are rampant, have never seen measles and don’t understand the seriousness of the disease. According to one public health official “They do not perceive the risk of the disease but perceive risk of the vaccine”. Also, unvaccinated children can serve as disease reservoirs or carriers and unwittingly infect older people (whose immunity has waned over time), immunocompromised individuals (cancer, autoimmune and HIV/AIDS patients)
 and even vaccinated children who failed to develop sufficient immunity.

So what does the anti-vaccine movement have to do with American science education?  Simply put, most Americans don’t understand the basic principles or fundamental concepts of biology and medicine. This should come as no surprise. According to recent surveys, 40% of Americans don’t graduate from high school. .Further, many college-educated non-science professionals have trouble discerning fact from fiction when it comes to science. Their lack of concern or disdain for science is frequently expressed in financial terms. Why should I become a scientist (with an advanced degree) and make $65,000 to $75,000 when I can make $75,000 to $100,000 a year with an undergraduate degree in business or finance? I don’t know–call me crazy– but sometimes there are more important things in life to consider than money–like vaccinating our children so that they are protected against potentially life-threatening diseases!

Until next time….

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

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