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During the Bush Administration I, along with many others, was a harsh critic of the US Food and Drug Administration (FDA). The criticisms that I levied against the agency were mainly based on its inability to adequately maintain the safety of the American drug and food supply and Bush’s repeated attempts to politicize the organization and render it useless. That said, it is amazing how much has and will change at the agency during the Obama Administration. To wit, Margaret Hamburg, the current FDA Commissioner yesterday announced plans that would dramatically transform the agency and largely change the way it does business.

In an unusually rare special report entitled “Pathway to Global Product Safety and Quality” Hamburg points out the monitoring problems currently facing the agency and proposes a four-point plan on how to fix them. To understand the importance of this document it is necessary to point out some little know facts about the American food and drug supply.

First, almost two-thirds of all fruits and vegetables and nearly 75 percent of all seafood consumed by Americans is imported. This year the number of these types of food shipments is expected to grow to 24 million through 300 or more ports. A little as a decade ago, the agency was responsible for overseeing and policing six million shipments annually. Second, it is estimated that over 80 percent of the active pharmaceutical ingredients (APIs) found in approved drugs are made in manufacturing plants found mainly in China, India and Latin America. Because of funding and “manpower” shortages, most of these API manufacturing facilities are rarely inspected for regulatory compliance. According to the report, many kinds of antibiotics, oncology drug and other medications are no longer produced in the US or in many cases anywhere in the Western world. Finally, roughly 50 percent of all approved medical devices sold in the US are made in foreign production facilities.

In 2008, government officials determined that the agency would need approximately 13 years to inspect all foreign drug manufacturing plants, 27 years to check every foreign medical device production facility and a whopping 1,900 years to check every foreign food production plant! This is because FDA has only several hundred inspectors who are empowered to perform these inspections. Consequently, only a fraction of the food and APIs imported to the US are inspected. For example, less than one pound in a million of imported seafood gets as much as a “visual inspection” to determine whether or not it is fit for American consumption. This led the report’s authors to contend that “the safety of America’s food and medical products remain under serious threat.”

Yet, despite this ongoing threat, Republican lawmakers last week voted to cut the agency’s budget rather than increase it to perform the necessary number of food and drug inspections. Further, the same lawmakers oppose any corporate or consumer fees, whether voluntary or forced, to help to underwrite the inspections calling them an unacceptable tax. This has forced the agency to enlist the help of regulators in other nations to create a global coalition or network to perform the required inspections to insure the regulatory compliance and safety of foods, drugs and devices imported into the US. While the FDA has limited cooperation agreements with regulators in Europe and other Western countries, it just recently stationed its own inspectors in emerging markets like China, India and Central America. In theory this should work. However, in the past, some of the governments of these countries have refused to fully cooperation with FDA. Further, and perhaps more problematic, is that regulatory agencies in some other countries are largely corrupt or nonexistent. Finally, some outspoken former FDA employees and critics contend that improvements in the communication between FDA in Washington and its field offices in US states may be necessary before the agency can effectively enlist the cooperation of foreign regulators.

There is no doubt that contaminated foods, counterfeit medical devices and tainted drugs are increasingly finding their way into the US. It is FDA’s legislated responsibility to insure that all foods and drugs sold in the US are safe and effective for all Americans. Republican lawmaker’s refusal to increase FDA’s budget to allow the agency to fulfill its mandate is unconscionable and indefensible. The safety and health of all Americans is critically important for the well being of the nation and ought to take precedent over budget shortfalls and a looming US trade deficit.

Until next time...

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

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Christopher Rutty, a science writer and historian and member of a LinkedIn Group that I belong to, posted a link to a Penn and Teller  YouTube video on childhood vaccinations.  I had no idea what to expect, but after viewing the video all I could say was "Wow, how brilliant."  I don't think that I have ever seen a more elegant and easy-to-understand piece on the science and ultimate benefits of childhood vaccinations! 

Hat tip to Penn and Teller and the creative folks behind the video!

Until next time,

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

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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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Depending upon the source, the cost of bringing a new prescription drug to market these days ranges from roughly $1.2 to 1.5 billion. While there is no question that clinical studies represent the most costly aspect of getting new drugs approved, the hidden costs—mainly promotion and marketing—are what actually inflate the costs of new drug development. Not surprisingly, drugmakers fail to disclose that these costs are included in the estimates for new drug development. If these costs were eliminated from the total, then the cost of developing new drugs will be significantly less than the current $1.2 to $1.5 billion price tag.

I suspect that many BioJobBlog readers—mainly those who work in the drug industry—will likely write me off as someone who doesn’t know what he is talking about. But, an interesting tidbit that I found in an article in today’s New York Times entitled “A Fight Over How Drugs are Pitched” suggests that my claims ought not be summarily dismissed simply because I am a “left-leaning histrionic democrat.” To wit, according to IMS Health (a competitive intelligence firm that tracks physician prescription rates) in 2009 alone, the branded prescription drug industry spent about $6.3 billion on marketing visits to doctors! This amount does not include costs associated with marketing and advertising that support direct-to-consumer (DTC) advertising campaigns that are run by companies that sell approved prescription drugs. DTC costs are generally much higher than those spent on direct marketing to physicians.

It is important to remember that a drug maker’s main goal is to convince physicians to prescribe “their” drugs. After all, physicians not patients write prescriptions! That said, physician prescribing behaviors are vitally important to the success or failure of a marketed prescription drug. Consequently, it should come as no surprise that marketing costs are factored into the cost associated with new drug development. Obviously, if less money was spent on marketing than the cost of bringing new drugs to market would likely be substantially less.

Interestingly, the States of Vermont, New Hampshire and Maine recently enacted laws to limit the uses of a doctor’s prescription records for marketing. On Tuesday, the US Supreme Court will hear arguments in a case, Sorrell v. IMS Health that tests whether Vermont’s prescription confidentiality law violates the free speech protections of the First Amendment. The federal government, the attorneys general of several dozen states, AARP, professional medical associations, privacy groups and the New England Journal of Medicine have filed briefs in support of Vermont’s law. The National Association of Chain Drugstores, the Association of National Advertisers and news organizations like Bloomberg and The Associated Press have filed briefs aligning themselves with the data firm.

Although a Vermont federal district court upheld the law after a lawsuit challenging the statute brought by IMS Health and the Pharmaceutical Research and Manufacturers of America, an appellate court overturned the decision suggesting that it violates free speech provisions afforded by the First Amendment of the US constitution.

It will be interesting to see how the “Supremes” adjudicate the appeal given the growing recognition that laws and regulations designed to control medical costs and minimize safety risks associated with newly approved drugs are becoming increasingly necessary.

Until next time...

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

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Last week, the US House of Representatives voted to cut FDA funding by $220 million. The House vote was not surprising given the prevailing attitude among many pharmaceutical and biotechnology company executives that FDA approval of new drugs and devices has become increasingly difficult. While there is no question that the current approval process for new drugs and devices has become more rigorous as compared with the incredibly lax process (and in some cases, the almost non-existent process) used during the Bush Administration, the FDA is simply fulfilling the mandate for the agency when it was created in 1938. That is: to provide the American public with SAFE and efficacious drugs to treat unmet medical need. 

Until recently, the FDA had been chronically under funded. And, because of this, the American public was forced to suffer through the Vioxx scandal, the heparin scare and the appearance on the market of many unapproved medical devices. These and other events that occurred over the past decade beg the question: “Should the American public’s safety be placed in jeopardy again simply because the Republican-controlled House is looking for ways to cut deficit spending?”

Unfortunately, the activity of anti-FDA lobbyists (funded mainly by US pharmaceutical and biotechnology companies) has been ramped up ever since the Democrats lost control of the House. And, since most Republicans believe that any government regulation whatsoever is too much regulation, it is easy to understand the House would vote to cut FDA funding. Nevertheless, insufficient funding will not allow the agency to hire the number of inspectors required to insure that drug manufacturing is conducted according to FDA-mandated regulatory guidelines. These activities are essential to insure the safety of the prescription drugs and medical devices sold on the US market.

According to FDA Current Good Manufacturing Practice (CGMP) guidelines, drug manufacturing plants for all approved drugs and devices are to be inspected every two years. Inspections are required for all manufacturing plants in the US as well as FDA-approved manufacturing facilities overseas. Because of ongoing shortages of FDA inspectors (and the emergence of numerous overseas manufacturing facilities), these inspections are typically conducted every three to five years rather than every two years! Clearly, this is not in the best safety interests of the American public.

A report published by the General Accounting Organization about the heparin scare of three years ago nicely sums up the issues.

“In its response to the heparin crisis, FDA took several actions related to its responsibility to protect the public health by ensuring the safety and security of the nation’s drug and medical device supplies. FDA increased its activities related to oversight of heparin firms by conducting inspections and investigations and monitoring heparin imports, and worked with drug and device manufacturers to recall contaminated products while ensuring that an adequate supply of uncontaminated heparin was available. With the help of external entities, FDA identified the unknown contaminant and developed tests to screen all heparin products. Additionally, the agency reached out to its international regulatory partners during the crisis. However, FDA faced some limitations in its efforts to inspect heparin firms in China and collaborate internationally, and the agency was unable to determine the original source of contamination.”

Interestingly, as today reported by the EyeonFDA blog, the U.S. House of Representatives Energy and Commerce Committee announced today that it was re-opening examination of the heparin contamination issue.  A letter was sent by the Chair of the Committee, Rep. Fred Upton (R-MI) as well as other members to FDA Commissioner Margaret Hamburg requesting that the agency supply all documents in connection with the heparin investigation from January 1, 2008 until present.  In its announcement, the Committee stated:

“It has been almost three years since the FDA linked deaths and serious allergic-type reactions of patients in the United States to supplies of heparin that came from the People’s Republic of China which was adulterated with overly sulfated chondroitin sulfate (OSCS). FDA officials believe this was an instance of economically motivated adulteration,” the members wrote. “However, neither the Chinese government nor the FDA has identified those responsible for the contamination or described how the heparin actually came to be contaminated.”

Mark Senak, author of  EyeonFDA blog aptly noted:

"It is certainly important in that any public health crisis involving the contamination of food or drugs be thoroughly investigated. But the investigating body can’t have it both ways. You can’t criticize an agency for not conducting inspections that are not funded by the same members of the same investigative body."

Is this any way to run a country?

Until next time...

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

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About a year ago I posted an article to BioJobBlog that suggested that social media can be leveraged to improve clinical trial recruitment to test investigational new drug candidates. Yesterday, Mark Senak, author of the EyeonFDA posted an article which suggested that the use of video on YouTube and other video-viewing sites makes complete sense to recruit prospective participants for human clinical trials. Here are some of Mark’s thoughts on the topic:

“The reasons I think video is a good way to expose people to learning about clinical trials are multiple. First, it allows me as a prospective clinical trial participant to learn about a clinical trial when I want to learn about it and where I want to learn about it - a hallmark of social media.  Second, it is private - I can learn from a video that can be developed to address a wide range of issues - issues that I might not be so comfortable addressing with a live person.  Thirdly, and perhaps most importantly, I learn about the clinical trials perhaps from someone on a video who is very much like me.  He can be someone with my condition - someone who has gone through a trial, and talk about how his concerns were addressed, what his fears were and what the benefits of participation were.  That, I think, is a much more convincing way to learn about a trial than an ad in a newspaper or even a discussion with a clinical person.  Video can't replace the medical professional, but it sure can get my interest and perhaps trust to make recruitment much easier.”

While the industry’s use of social media for this purpose is not quite there yet, there are some signs that pharmaceutical and biotechnology companies may be trending in that direction. First, a growing number of clinical research organizations (CROs) which help companies plan and manage clinical studies are already using social media tools to recruit prospective clinical trials participants. Second, as Mark reported yesterday, Pfizer launched a YouTube channel called PfizerClinicalTeam last July which presumably would bolster clinical trial recruitment. Unfortunately, as Mark pointed, its most recent video was posted in April, 2010, regarding a new study on schizophrenia. Don’t be surprised if other companies launch social media-focused clinical trials recruitment campaigns in the not too distant future. Like Mark, I believe that social media tools are ideal for this purpose!

In other news, Pfizer, a late entrant to the fledgling pharmaceutical social media space, is showing signs that it is beginning to embrace the social media web. Yesterday, Pfizer and Epocrates announced a collaboration to create an application for the iPhone that gives healthcare providers mobile access to the Pfizer Medical Information Group to obtain medical and science information about Pfizer products or to report adverse events. According to Pfizer, it is creating the app to: “enable easy, direct access to its Medical Information services, via the Epocrates channel, in an effort to enhance the safe and effective use of its medicines, and help improve the quality of patient care.”

Direct access to medical information via mobile devices is growing in popularity among physicians and other healthcare providers because it enables them to get answers on the go without wasting time to fire up a laptop or find a tethered computer to use outside of the clinic.

Despite assertions to the contrary by most pharmaceutical and biotechnology companies, social media tools are ideal vehicles for adverse event reporting and post market drug surveillance activities. Pfizer’s creation of a mobile medical information app coupled with the launch last week of a joint US Food and Drug Administration (FDA) and National Institutes of Health drug safety portal called Safety Reporting Portal (original eh?) suggest that the use of social media tools for online adverse event reporting and drug safety purposes is not too far off. Let’s see what develops over the next year or so after FDA issues regulatory guidance on the use of social media in the life sciences industry.

Until next time...

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

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Medicis Pharmaceutical, the maker of Dysport a drug approved by the US Food and Drug Administration (FDA) to smooth skin furrows between the eyebrows, recently introduced a marketing campaign that offers people who use Dysport drug discounts and a patient satisfaction rebate guarantee. The campaign, which runs through April 30, was intentionally designed to elevate Dysport’s image and cannibalize market share in the anti wrinkle market from Allergan the maker of Botox and the market leader.

The Dysport promotion, running on the product’s Web site and in a few glossy magazines like Us Weekly, offers a $75 rebate check on an initial Dysport treatment for wrinkles between the eyebrows, a procedure that can cost consumers $300 to $500. Satisfied customers can receive a $75 rebate on a follow-up Dysport treatment, while dissatisfied customers who want to switch can receive a $75 rebate on a Botox treatment.

While this is an unprecedented and novel campaign, it demonstrates the lengths that Medicis is willing to go through to garner market share from Botox which enjoyed a monopoly on injectable toxins in the US until the introduction of Dysport last year. Last year, worldwide sales of Botox were roughly $1.3 billion. Industry analysts estimate that Medicis may be able to capture a 20 to 25 percent share of the US market.  

While the marketing campaign may seem a bit odd and brash, Medicis isn’t the first pharmaceutical company to use rebates and drug discounts to inspire patient brand loyalty. For example, Sepracor offers a seven-day free trial of its popular sleeping pill Lunesta. Merck is running a print ad with a voucher for a free 30-day supply of its Januvia tablets for Type 2 diabetes. Another Merck ad carries a $20 coupon for the allergy and asthma drug Singulair. However, the use of product rebates and drug discounts is mostly used to market so-called vanity medicine drugs (like Latisse, Botox and Dysport) which have been approved by FDA for clinical use but are not covered by medical insurance. Patients who use these drugs are paying out of pocket and, in essence, are buying from physicians. Many worry that this practice may induce doctors and patients to make medical decisions based on money not safety or efficacy. 

In the case of Botox and Dysport neither product is entirely risk free. For those of you who may not know, both are purified forms of botulinum toxin — a toxin produced by Clostridium botulinum that interferes with nerve transmission and involuntary muscle contractions. The injections cause temporary cosmetic problems like droopy eyelids or uneven eyebrows. And these drugs now carry federally mandated “black box” warnings on their labels stating that botulinum toxins have been associated with rare but potentially life-threatening health problems.

Although promotional programs like the one being offered by Medicis may be inappropriate or seemingly reckless, it—like those of Sepracor and Merck—are permissible under current direct-to-consumer (DTC) advertising regulations. Isn’t it time to reevaluate regulations that allow powerful, potentially-dangerous prescription drugs to be treated as consumer goods where price, not medical need, safety or efficacy, promotes their acceptance and use?

Until next time...

Good Luck and Good Looking!!!!!!!!!!

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There was an interesting article in the New York Times this past week entitled“Do Women Need Such Big Flu Shot.” The gist of the article was that we would have more doses of influenza 2009 H1N1 vaccine if we accounted for the biological differences between the immune responses in men and women follow influenza vaccination (the article cites a study that contends that less vaccine is need to elicit an protective response in women as compared with men.

I was going to write a post about the article but I got distracted and thought I would revisit it when I had more time. Much to my surprise, Vincent Racaniello, a Bio-Crowd founder, virologist extraordinaire and host of the popular TWiV podcast series, had already “scooped” me. Professor Racaniello graciously allowed me to crib his entire post and let BioJobBlog readers decide for themselves whether or not there are real differences in the male and female immune responses to influenza vaccines or the results obtained by the scientists who conducted the study may be explain by strain to strain variation among influenza A isolates? Read Professor Racaniello’s post below and let me know what YOU think!

Do women need the same amount of influenza vaccine as men?

by Vincent Racaniello

“Do Women Need Such Big Flu Shots?” suggests that we would have more doses of influenza 2009 H1N1 vaccine if we accounted for the biological differences between men and women. The idea is that women generate a stronger antibody response than men, and therefore require less vaccine. Does this idea have scientific support?

The opinion is based in part on a study carried out in 2004-05, in which adults were immunized with full (15 micrograms) or half-doses of trivalent inactivated influenza vaccine. This vaccine, made by Aventis Pasteur, contains influenza H3N2, H1N1, and B strains. Serum samples obtained before immunization and 21 days later were assayed for antibody response to each strain of influenza by hemagglutination-inhibtion. I’ve taken the data on geometric mean serum HI titers according to age, sex, and dose and plotted them on a graph:

Based on the results the authors conclude that “Significantly higher geometric mean titer responses in women were identified for all ages, regardless of dose or influenza strain. Half-dose vaccination may be an effective strategy for healthy adults younger than 50 years in the setting of an influenza vaccine shortage.” But are these immune responses protective?

HI titers of 1:40 or more (which would be reported as 40 or higher in the graph) are believed to indicate levels of antibody that would protect against infection with influenza virus. By this criteria, the full and half dose of vaccine would provide protection agains the influenza H3N2 and B viruses in both men and women. The results confirm that females respond more strongly to the same dose of vaccine than men. But look at the results with the H1N1 strain – in all subjects, no matter the dose of vaccine or gender, the antibody response would not be sufficient to protect against infection. Furthermore, the response is only slightly better than in women.

In interpret these observations to mean that the antibody response to inactivated influenza virus vaccine is not universally more robust in women compared with men – it appears to depend on the virus strain. Clearly clinical studies are required to address this question. Even after spending millions of dollars to decide whether to give women less influenza vaccine, a new strain of influenza virus might come along that induces no better antibody response in women than in men.

My conclusion is that it would not be possible to determine conclusively that women could receive half the amount of inactivated influenza virus vaccine as men. I would rather spend money on developing new ways to produce as much influenza vaccine as needed as quickly as possible – such as by making virus-like particles in plants.

Engler RJ, Nelson MR, Klote MM, VanRaden MJ, Huang CY, Cox NJ, Klimov A, Keitel WA, Nichol KL, Carr WW, Treanor JJ, & Walter Reed Health Care System Influenza Vaccine Consortium (2008). Half- vs full-dose trivalent inactivated influenza vaccine (2004-2005): age, dose, and sex effects on immune responses. Archives of internal medicine, 168 (22), 2405-14 PMID: 19064822

 Until next time...

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The New York Times reported today that AstraZeneca has agreed to pay $520 million to settle two federal investigations and two whistle blower lawsuits over the sale, marketing and off-label promotion of its blockbuster antipsychotic drug Seroquel. Despite this settlement, UK-based AstraZeneca still must contend with 14,444 civil lawsuits filed by many patients who developed diabetes and other health related conditions because of misleading marketing that failed to adequately disclose that the drug caused abnormal weight gain.                     

AstraZeneca joins a growing list of pharmaceutical companies that have been penalized for off label promotion and misleading advertising. Earlier this year Eli Lilly & Co paid $1.4 billion over its marketing of another antipsychotic drug Zyprexa and Pfizer announced that it would pay $2.3 billion including a record-breaking criminal fine of $1.195 billion mostly for its painkiller Bextra which was withdrawn from the market.

Despite the size of the fines and settlement figures for these recent cases, they are a drop in the bucket when compared with the amount of money generated by illicit marketing and advertising. For example, the $520 million that AstraZeneca has agreed to pay to settle the Seroquel case pales in comparison to the $17 billion that the drug has generated in US sales since 2004. The same was true for Zyprexa and Bextra.

While these settlements cannot repair much of the damage that has been done to unknowing patients, it signals that the US government is beginning to live up to its pledge to provide safe and efficacious medicines to the American public.

Until next time...

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

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I regularly watch Real Time with Bill Maher and generally agree with many of the political views and ideas that he espouses. In fact, I am a fan! However, his rant two weeks ago about the H1N1 vaccines, and vaccination in general, showed me that while politically astute and incisive he has absolutely no understanding about science and modern medicine (see video below). Making matters worst, his guest, former conservative senator Bill Frist, a surgeon by training, was ill prepared to correct and refute some of Maher’s outrageous assertions regarding the differences between the two currently available H1N1 vaccines and the basic principles of vaccinology.

Maher is quick to tell people that they are stupid when they don’t agree with his ideas or political views. And, he rightfully criticized George W. Bush for routinely making decisions about important issues based on “his gut feelings” rather than facts. Ironically, this is exactly what Bill Maher does when he talks to his guests about medicine and food. Maher, who may be a vegetarian and is clearly anti-traditional medicine,  is quick to point out that Westernized medicine and food production is profit driven and consequently, any information or advice offered by the US government is little more than a ploy to keep people sick and fat. In other words, don’t trust anything that the government tells you if you believe otherwise or you heard it from a celebrity. 

I suspect that science wasn’t Bill’s “cup of tea” (he frequently calls the tea baggers who don’t trust anything that the Obama administration tells them idiots and morons) and may have never taken anything he learned about science seriously. If he had, he might have learned how vaccines work and realized that modern vaccines (the first vaccines were produced in the 1780s) protect over 95% of people who receive them from devastating childhood diseases and even cervical cancer. Instead, he cites bogus and scientifically refuted claims about vaccine safety including mercury poisoning, links to autism and the miniscule possibility of developing Guerin-Barr Syndrome (which was first observed in large number of patients following vaccination with the 1976 Swine Flu vaccine). Shockingly, despite incontrovertible evidence to the contrary he continues to spew misinformation and flat-out wrong claims about vaccines. Ironically, his wrong-headed vaccine tirades are remarkably similar to those of the Birthers —people who refuse to believe that President Obama is an American despite incontrovertible evidence to the contrary—and racists who contend that Obama is a Muslim—two groups that he is quick to bash and dismiss as crazies and morons. In other words, Maher believes that he is right even though he is clearly misinformed or wrong!

Originally, I was going to write this post after Maher’s “Real Time” tirade about vaccines almost two weeks ago on Real Time. However, I relented but couldn’t help myself after reading an article in today’s Scientist Times about a pregnant woman who lost her second child after she contracted the flu. As many of you may know, pregnant women are very susceptible to influenza which could have serous consequences for the mother and baby. This is an exchange the woman had with a physical therapist with whom she was working to regain muscle control after being hospitalized (and near death) for almost 4 months:

“Have you ever read the labels?” she (the physical therapist asked). “They’re so full of toxins.”

Asked if she realized that a shot, had it existed in June, might have saved her client and her baby, she frowned and went back to her clipboard.

Are you kidding me—full of toxins? This is exactly what Maher was trying to imply during his anti-vaccine rant on Real Time. Unfortunately, millions of people listen to him and celebrities like Oprah, Dr. Phil and Maher and many believe (and blindly follow) their recommendations and advice. While this may not be a problem when talking about hair color, books to read or weight loss it is extremely troubling and dangerous when it comes to scientific and medical advice. The problem is that a vast majority of Americans are scientifically illiterate and are either incapable or unwilling to analyze and evaluate scientific or medical information on their own. This forces many people to rely on the Internet, government agencies and sometimes healthcare professionals to do their medical and scientific thinking for them. And when things go wrong, or not as advertised, they are quick to accuse the government or the healthcare industry of withholding information and engaging in nefarious conspiracies. This is exacerbated by the fact that science and medical reporting in the US is grossly inadequate, often wrong and frequently designed to be as sensationalistic as possible. Is it any wonder why the American public is often confused and misinformed about science and medicine?

My scientific training has taught me to analyze and evaluate all available data before I draw any conclusions on a topic. And, as an infectious disease expert I believe that childhood vaccines are unequivocally safe and effective. To that end, they have substantially reduced the morbidity and mortality associated with mumps, measles, diphtheria, whooping cough, pneumonia, tetanus, almost eradicated polio and eliminated smallpox from the planet. There is no doubt that there are risks associated with vaccination and that a small number of those vaccinated may experience some side effects or serious adverse events. But, the small risks associated with modern vaccines don’t outweigh the benefits and positive effects on billions of people who may have lost their lives if they hadn’t been developed in the first place. I wonder whether or not an anti-vaccine movement would exist today if smallpox and polio were still causing as much death, disfigurement and paralysis as they had prior to development of the smallpox and polio vaccines in the mid 20^th century.

In closing, as an American, I believe that everybody is entitled to their opinions and the right to freely express them. However, I implore Bill Maher get the FACTS right before summarily bashing a topic and making recommendations to the millions of people who watch Real Time and believe what he says. Otherwise, he is no smarter or better than the ignorant, close-minded, right wingers who he regularly trashes on his show.

Until next time...

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

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One day after the US Food and Drug Administration (FDA) approved Dysport, a new product that will compete with Botox, the agency ordered that labels for all botulinal toxin-based drugs must carry a black box safety warning. For those of you who may not know, that is the most stringent kind of safety warning label—viewed by many in the industry as “the kiss of death”— that the agency can order to appear on the products that it regulates. 

Black boxes (literally a black box with bold-face risk information) are typically reserved for medications that are know to have serious or life-threatening side effects or risks. For example, many antidepressants—most recently serotonin re uptake inhibitors (SRIs)—carry black box warnings of increased danger of suicidal thoughts and actions. 

Over the last 20 years FDA approved Botox to treat crossed eyes, eyelid spasm, severe underarm sweating and cervical dystonia (a painful and severe neck condition that can cause an abnormal head position) Cosmetic Botox was approved to treat skin folds and wrinkles in 2002. Allergan, the company that manufactures Botox, reported $1.3 billion in worldwide sales of the drug in 2008. 

Botox and Dysport are injectible products made from the highly paralytic toxins produced by the bacterium Clostridium botulinum. Botulinal toxins interfere with muscle contractions and patients with botulism food poisoning exhibit what is known as “flaccid paralysis.” Afflicted individuals cannot breather and will die without early intervention. FDA order the black box safety warning labels because there were numerous reports of serious health problems, complications and deaths caused by the drug spreading from the site of injection to other parts of the body. 

Most of the problems with Botox resulted from the overuse of Botox for unapproved treatments like limb spasticity in children with cerebral palsy (although misuse of the product for cosmetic purposes may have also contributed to the problems). The agency will now require that all botulism-based products carry a black box warning explaining that the medication has the potential to spread from the site of injection to other body sites—with the potential to cause serious problems like difficulties swallowing or breathing. Also, it will require manufacturers of botulinal products [Allergan (Botox) and Ipsen/Medicis Pharmaceuticals (Dysport)] to send physicians letters warning of the risks and to craft medical guides given to patients at the time of injection. 

The new warning labels will likely do little to discourage the rampant use of Botox and Dysport for cosmetic indications. After all, beauty will always come before safety! 

Until next time... 

Good Luck and Good Job Hunting (looking younger may help)

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Tainted pistachio nuts are the culprit for this week’s Salmonella outbreak.  Fortunately, Kraft Foods’ quality unit was doing its job and was able to alert consumers about the problem before the outbreak reached epidemic proportions. At present, there are only two suspected cases of Salmonella gastroenteritis that may be linked to tainted pistachios. The contamination has been traced back to a California company which, according to reports, is the second leading producer of pistachios in the US.

As I have mentioned several times before, Salmonella outbreaks are nothing new and not out of the ordinary in the food industry. However, what is new is the growing lack of regulatory compliance that seems to be pervasive at American food manufactures. Many blame declining food safety on the US FDA’s lack of trained inspectors. While this may play a role, I believe that the real problem lies with the failure of many food industry executives to make a commitment to quality outlined in FDA’s Current Good Manufacturing Practices (cGMPs). 

I have been teaching cGMP to biotechnology students for the past six years or so.  I always tell them that the regulations are meaningless unless management makes a commitment to quality. And, the only way to accomplish this is by insisting that all manufacturing taking place at a company stringently adheres to all GMP regulations and guidelines. For those you who may not be familiar with cGMPs, they are the minimum regulatory standards that must be met to insure US product (food, drugs and cosmetics) quality and safety.

Over the past decade or so, Americans have grown accustomed to a wide variety of choices when it comes to raw and processed foods. To meet demand, US food manufacturers must source and import fruits, vegetables, spices and other foodstuffs from all over the world. Regardless of the origin of a food source, cGMPs clearly state the onus is on the manufacturer (not the supplier) to perform the necessary tests to insure food safety and quality. The recent spate of Salmonella outbreaks suggests that some food manufacturers are either cutting corners or don’t fully understand what testing is necessary to guarantee food safety. Unless something changes, Americans confidence in the safety of US food supply will continue to wane.

Until next time...

Good Luck and Good Easting (avoid pistachios)

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I just returned from a weekend of teaching regulatory affairs to biotechnology students at Georgetown University where I tried to convince them that the US Food and Drug Administration (FDA) is fundamentally sound despite its near demise during the Bush administration. Even before the Bush-induced wreckage, the agency was chronically understaffed, under funded and had serious leadership and morale problems. This, coupled with two nationwide Salmonella outbreaks in the past year, several highly publicized drug recalls, and steadily declining drug approval rates has prompted its critics to propose that FDA be split into two separate agencies—one that oversees the drug industry and another that would have responsibility for cosmetic and food safety. For those of you who may not know, FDA became responsible for oversight and regulation of the food and drug industries, in addition to the drugs, after passage of the Food, Drug and Cosmetic Act in 1938.

Drug industry advocates and longtime FDA critics contend that the agency as it exists today can no longer effectively oversee and insure the safety of American food and drug supplies. Critics argue that the history of FDA suggests that the agency focuses on medical products and only focuses on food safety when a crisis comes up. And when they occur, FDA is so distracted that it interferes with the drug review/approval process. While this is what FDA critics want you to believe, it is simply not the case. Despite its recent problems, the FDA has historically done an outstanding job when it comes to drug and food safety—when it is funded and staffed to appropriate levels.

Unbeknownst to the American public, food borne illnesses are very common and Americans are only alerted when the outbreaks reach a certain size. While the recent Salmonella outbreaks were larger in scope and breadth than past outbreaks, they were not extraordinary. However, they were extremely media worthy at the time that they were reported on. You may recall that at the time of the outbreaks, the American economy was beginning to fail and there was an inordinate amount of China, Mexico and free trade bashing going on in the US. Unfortunately, the news media decided to exploit the outbreaks to make a case that Americans ought to reduce their reliance on imported foods—a practice that was beginning to cut into the revenues of the US agriculture and food industries. Ironically, the Salmonella outbreaks might have been prevented if the production facilities (owned by American companies) were compliant with FDA mandated quality control and assurance regulations which were designed to insure food safety.

Drug industry advocates who argue that FDA ought to be split into two separate agencies have financial interests rather than safety concerns in mind.  As an investment banker or VC will tell you, slow, new drug approval rates can have serious financial consequences for the companies that are developing them—it can literally cost a company millions of dollars a day for every day the drug is kept off the market.  Interestingly, when FDA increased its drug approval rates in the late 1990s and early 2000s, there weren’t many industry insiders advocating a break up of the agency. Only recently, as FDA has become more risk adverse which in turn, has caused the new drug approval rates to slow again have critics begun to call for massive organizational changes at FDA.

Like I told my biotech students over the weekend, the only mechanism by which FDA can insure food and drug safety is by conducting regular inspections of drug and food manufacturing facilities. Unfortunately, FDA hasn’t been able to keep up with its mandatory inspections schedule because the agency has been under funded and poorly staffed for over a decade. Several FDA inspectors, who I talked with suggested that routine inspections of manufacturing facilities takes place every three to five years rather than every two years as required by FDA regulations. While in theory this shouldn’t affect a company’s ability to remain compliant with FDA regulations, in reality it does. Put simply, pharmaceutical and food companies, like most other for profit industries are incapable of policing themselves in the absence of regulatory oversight.

I ‘m not certain that the agency needs to be split into two separate agencies to continue to insure the safety of the American drug and food supplies. What I know is the agency needs more funding and much larger numbers of trained inspectors to be successful. In my opinion, the safety of the American food and drug supplies can only be guaranteed if the companies regulated by FDA make a commitment to quality manufacturing and play by the rules.

Until next time...

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

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An article in today’s New York Times reports that several FDA scientists have accused the agency of granting market approval to several unsafe medical devices. According to published reports, “the House Committee on Energy and Commerce will investigate the accusations, first aired when eight agency scientists wrote a private letter in May to FDA commissioner Andrew von Eschenbach.”

Unfortunately, the allegations made by the eight scientists against the agency are nothing new. Frequently, agency managers (and sometimes political appointees) lean toward approving drugs or devices when the data pertaining to efficacy and safety are equivocal.

My sources at FDA suggest that this is what happened with approval of Merck’s ill-fated pain medication Vioxx.

Recently, there has been a spate of safety claims made against medical devices manufacturers. This is not surprising because the regulatory hurdles for marketing approval of devices are much lower for devices as compared with drugs and the medical devices and diagnostics business is the fastest growing sector in the life sciences. For an overview of the medical devices and diagnostics industry please read my recent article published in Science Careers.

Hopefully, new leadership at the agency will turn things around!!!!!!!

Until next time…

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

.

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The Pharmalot blog reported today that Merck received approval from the US Food and Drug Administration to use Gardasil to prevent vaginal and vulval cancer in addition to cervical cancer.

Of late, Gardasil has been a lightening rod for controversy—mostly because of Merck’s unrelenting marketing campaigns (and the behind-the-scenes lobbying for the vaccine to be placed on the US mandatory vaccination list)  coupled with the Christian right’s moral machinations about premarital sex and sexually transmitted diseases in general. Also, let’s not forget the brouhaha surrounding FDA’s decision to delay approval of GlaxoSmithKline’s competing cervical cancer vaccine called Cervarix. Finally, about a month ago, there was study published in the New England Journal of Medicine questioning the cost effectiveness of Gardasil vaccination of women after the age of 18.

Regardless of your moral, ethical or business concerns about Gardasil, the bottom line is this: girls/women vaccinated with Gardasil are much less likely to develop cervical cancer as compared with those who are not vaccinated.

As I have mentioned before, all approved and marketed drugs have side effects and possible safety/tolerability issues. More importantly, the decision to approve a particular drug is always based on a careful risks/benefits assessment by government healthcare regulators. Whether or not a person uses a drug or vaccine is ultimately a personal choice. With the exception of mandatory childhood vaccines (children can be exempted for moral or religious reasons), every American has the right to decide whether or not to use a medication or undergo a treatment recommend by a healthcare professional. Based on everything that I have read about Gardasil, it appears to be a safe and effective vaccine to prevent cervical cancer. When FDA finally approves Cervarix (probably sometime in late 2009), it will offer women who may have concerns about Gardasil with an alternate vaccine to protect them against developing cervical cancer.

The funny thing about the Gardasil firestorm is that cervical cancer isn’t a major healthcare problem in the US. This is because a majority of American women undergo annual routine gynecological examinations (that include pap smears, the current gold standard for cervical cancer detection). In contrast, cervical cancer is a major healthcare problem and economic concern in Asia, most notably in China and India. This begs the question—why are Merck and GSK so intent on selling their cervical cancer vaccines in the US? Put simply, there is still much more money to be made in the US than in Asia. Look for approval of Gardasil and Cervarix in China and India when the middle class of both countries reach a critical mass.

Until next time…

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

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A post at the Pharmalot blog said that the US FDA and the Centers for Disease Control issued a statement today indicating, that after reviewing side effect reports, Merck’s anti-HPV (cervical cancer) vaccine Gardasil is safe and effective, and its benefits continue to outweigh its risks.

According to the statement, the joint agency review determined that 94 percent of  all side effects reported after Gardasil vaccination were not serious. The most commonly reported adverse events fainting, pain at the injection site, headache, nausea and fever. Fainting is common after injections and vaccinations, especially in adolescents, the agencies noted.

Although there have been 20 reported deaths following vaccination, there was no common pattern or tend that would suggest they were caused by the vaccine itself. The statement went on to say that in cases where autopsy, death certificate and medical records were available, the cause of death was explained by factors other than the vaccine.

The statement was likely issued in response to highly publicized and widely circulated adverse events reports issued by the ultraconservative Judicial Watch which is morally opposed to HPV vaccination. It is extremely unfortunate that a small but vocal group of conservative Christians are willing to risk the health of their daughters because they are morally opposed to premarital sex and birth control. 

Until next time….

Good Luck and Good Job Hunting!!!

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The old adage “When it rains, it pours” is particular apt for the bad news that has plagued the once venerable Merck & Co for the past five years. First, there was the Vioxx scandal, followed in short order by the Vytorin and Singulair messes and now it appears that the company’s new anti-cervical cancer vaccine, Gardasil, may have —pardon the expression — a few “warts” on it. 

Last night on my local nightly news, there was a brief report about emerging safety issues with Gardasil. According to the report, adverse events ranging from “massive wart outbreaks to seizures and paralysis” have been reported for the anti-HPV vaccine. Since its approval in 2006, over 8,000 adverse event reports (the total number of people vaccinated was not disclosed) and 18 alleged deaths have been reported for Gardasil (although none of the deaths has been directly linked to Gardasil vaccination). This news comes on the heels of a recent Wall Street analyst’s report indicating that sales of Gardasil are much lower than expected. It appears that the vaccine, once considered by Merck insiders as the new blockbuster that could save the flagging drug maker, may, after all, be relegated to specialty drug status.

As many of you may know, GlaxoSmithKline (GSK) is seeking US approval for its anti-cervical cancer vaccine called Cervarix. Although Merck beat GSK to market, Cervarix has undergone more clinical testing and allegedly may have a better safety and tolerability profile than Gardasil (only the regulatory agencies know for sure). Nevertheless, it is not clear whether GSK will benefit or be injured by the negative publicity that Gardasil is receiving. As I mentioned in a previous post, the US Food and Drug Administration (FDA) recently delayed Cervarix’s approval pending submission of additional data that the agency requested from GSK.

Before anybody puts a nail in Gardasil’s coffin, it is important to point out who started the recent firestorm about the vaccine. It was none other than the conservative-funded public interest group Judicial Watch. It is no secret that this group advocates abstinence over condom usage and other methods to prevent sexually transmitted diseases. Further,  I suspect that a majority of Judicial Watch’s members don’t believe sex education or pre-marital sex for that matter. Finally, I have no doubt that Judicial Watch received some support (financial, spiritual or otherwise) from the anti-vaccination lobby that is unfortunately gaining strength in the US and elsewhere.

From a scientific standpoint, it is difficult to get a real measure of the safety of a vaccine until it has been widely used by large numbers of people. Although pivotal Phase III trials are required for all vaccine approvals, the number of people studied in these trials (sometimes in the tens of thousands) is not sufficient to predict all possible safety problems that may emerge when the vaccine gains widespread use. For this reason, regulatory agencies typically require vaccine manufacturers to conduct mandatory post marketing Phase IV clinical trials that are designed to address the seriousness of any possible safety concerns that may have emerged after a vaccine has been on the market for several years. Because all vaccine makers know this, it is still not clear to me why Merck, a company which has been in the vaccine business for a very long time, embarked on its failed lobbying campaign to get Gardasil on the mandatory US vaccination schedule shortly after it was approved. 

As I have said in the past, ALL pharmaceutical and biotechnology drugs have side effects and their occurrence and severity varies from person to person. Generally speaking, most drugs are approved by regulatory agencies because their potential benefits outweigh real or presumed safety risks. That said, the question facing all parents who have daughters is: Does protection against cervical cancer outweigh any adverse events or potential safety risks associated with Gardasil or Cervarix vaccination? It is a tough question but one that my wife and I and others will have to answer for our daughters!

Until next time…

Good Luck and Good Job Hunting (avoid Whitehouse Station, NJ)!!!!!!!!!

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According to a press release by IMS, a company that tracks pharmaceutical sales, growth of the US pharmaceutical market shrank from 8% in 2006 to a meager 3.8% in 2007–the slowest growth rate since 1961. Total U.S. prescription sales in 2007 only reached $286.5 billion. The 2007 slowdown in sales was attributed to:

• Loss of patent exclusivity for branded products
• Fewer new drug approvals
• Effect of Medicare Part D on annual growth
• Renewed focus on safety issues by US Food and Drug Administration

Industry officials place the blame for the slow down on FDA because fewer newer drugs were approved in 2007 as compared with years past. However, I believe that the slow down has more to do with:

• Higher prices of branded medications as compared with generic drugs
• Lack of public confidence in the pharmaceutical industry
• Increased scrutiny by regulators on direct to consumer advertising and continuing medical education (CME)
• Fewer and less innovative drugs in company pipelines

Bashing FDA is easy. The willingness of the pharmaceutical industry to assume ownership of some of its own shortcomings and missteps is substantially more difficult to do!

Until next time….

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

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Erythropoietin (EPO) is a hormone (protein) that regulates red blood cell production in humans. Back in the 1980s, scientists at a fledgling biotechnology company called Amgen determined that recombinant EPO was highly effective for treating anemia. Amgen owned the intellectual property rights to the EPO gene and decided to sell the recombinant protein encoded by EPO (called epoetin) as a treatment for anemia.EPO is known to alleviate fatigue caused by anemia by stimulating red blood cell production.

Amgen’s first EPO product, called Epogen, was approved in 1989 to treat patients suffering from anemia associated with renal failure. Procrit, Johnson and Johnson’s version of EPO (which was licensed from Amgen) was approved four years later in 1993 to treat chemotherapy-induced anemia. Aranesp, a longer acting version of EPO which is also manufactured by Amgen was approved in 2001 for anemia associated with chronic renal failure and in 2002 for chemotherapy-induced anemia in cancer patients.  All of the EPO drugs have gained blockbuster status and, over the past five years or so, the annual revenue generated by these drug is estimated to be $6.0 to $12 .0 billion.

Since their approvals, EPO, Aranesp and Procrit have been administered to tens of millions of kidney dialysis and cancer patients undergoing chemotherapy with minimal safety concerns and generally positive outcomes. However, with the looming specter of generic biologics (EPO lost patent protection in 2004) and competition from companies like Roche developing competing EPO products, Amgen stepped up its efforts to promote and sell EPO and Aranesp. This, in turn, caused EPO drugs to be used by many physicians, which ultimately resulted in additional safety warnings and a label change for all EPO products. The label change coupled with unrelenting negative publicity about Amgen’s promotion of its EPO franchise, caused its stock price to plummet and forced the company late last year to lay off 14% of its workforce.

Like other biotechnology and pharmaceutical companies, Amgen sought to find ne indications for its EPO products. To that end, there was some compelling evidence several years ago which suggested that EPOmight increase survival of cancer patients, when used with radiation and chemotherapy. The idea was that higher oxygen levels in the blood would make the radiation or chemotherapy being used to treat the patients' cancer more effective. With this in mind, several groups of investigators initiated human clinical trials to determine whether EPO treatment would benefit non-anemic cancer patients. Unfortunately, the New York Times reports that results from no fewer than eight clinical trials suggest that EPO drugs might actually promote rather than slow tumor growth and hasten the death of cancer patients.

Amgen believes that the increased trial deaths among EPO-treated patients resulted from blood clots rather than by promoting tumor progression or growth. The company contends that the amounts of EPO used in the trials exceeded what is recommended in the drug label and, at those levels, blood clots are a known common side effect. On the other hand, there is a growing body of evidence from a variety of sources which suggests that some types of human tumors express EPO receptors, which when stimulated by EPO binding, induces tumor cell proliferation. To make matters worse, when Procrit was first approved to treat chemotherapy-induced anemia, FDA regulators suggested in briefing documents that there may be a “hypothetical risk” that EPO could stimulate tumor cell growth. Nevertheless, neither FDA nor most EPO experts believe at this time that a direct link between EPO use and tumor growth has been established. Everyone agrees that more research must be conducted to verify or refute this idea.

Tomorrow, an advisory committee to FDA will consider placing further safety restrictions on the use of EPO drugs.  If they feel that blood clots were responsible for increased death among EPO-treated cancer patients then the recommendation would be relatively simple–only use the recommended modest levels of EPO to treat cancer patients as indicated on the product label.  However, if they believe that EPO directly stimulates tumor growth then even the currently recommended modest doses of the drug may be too risky to treat cancer patients. Regardless of the outcome of the tomorrow’s FDA advisory meeting, it is clear that Amgen’s flagship EPO franchise may be in serious jeopardy.

Until next time….

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

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Can anything else go wrong at Amgen? FDA regulators said on Thursday that they were reviewing the results from two recent studies that provided more evidence of serious risks for some cancer patients treated with anemia drugs, sold by Amgen Inc (Epogen & Aranesp) and Johnson & Johnson (Procrit). For those you who don’t know, J&J licensed Procrit from Amgen so there is really little difference between J&J’s Procrit and Amgen’s Epogen. Aranesp is a second generation, longer-acting version of Amgen’s Epogen.

In the studies, researchers used  Aranesp or Procrit to elevate a patient's level of hemoglobin to 12 grams per deciliter or higher, although many patients did not reach that level. Current warnings on the drugs say hemoglobin levels should not rise above 12 for patients with cancer. The FDA said the studies showed that patients with breast or advanced cervical cancer who were treated with the drugs died sooner, or had more rapid tumor growth, than similar patients who were not given the medications.

Based on these new data, it is almost certain that the agency will insist on label changes to include strong warnings regarding the use of EPO drugs to treat oncology patients. Maybe there is a black box warning in Amgen’s future?

Amgen's stock hit a new 52-week low on Thursday, dipping down to $45.25 and closing at $45.69. It has traded as high as $76.95 in the last year but has taken a beating with the decline of its anemia-drug franchise.

The similarities between Amgen and Pfizer are becoming more apparent each day. Both are largest companies in their respective sectors (biotech and pharma) and have relied almost exclusively on blockbuster franchises (and weak pipelines) to bolster their stock prices! As you may recall, both companies have laid off large numbers of employees over the past year to cut costs. Maybe bigger (biggest) is not always better?

Until next time….

Good Luck and Good Job Hunting!!!!

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The New York Times reported today that an independent study that analyzed thousands of older people with diabetes found that those treated with the widely used drug Avandia had significantly elevated risks of heart attack and death.

According to the Times article, the finding, published on Tuesday, in this month’s Journal of the American Medical Association (JAMA), could rekindle the debate about whether Avandia, a controversial treatment for Type 2 Diabetes, should remain on the market. Earlier studies drew similar links between Avandia and cardiac risks.

The new study concludes that Avandia users had a 60 percent increased risk of heart failure, a 40 percent increased risk of heart attacks and a 30 percent increased risk of death compared with patients taking other oral diabetes medicines.

Sales of the drug, formerly a $3.4 billion product globally, have declined sharply since June 2007 when an article appears in the  questioning the drug's safety.

Not good news for GSK. The big question now is whether the company ought to cut its losses and take Avandia off the market or continue to squeeze as much money out of the product until lawsuits begin to accumulate.

Until next time…

Good Luck and Good Job Hunting (not at GSK)!!!!!!!!!!!

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In an attempt to dispel the notion that it is “dysfunctional” and "lax in policing drugs once they are on the market", the US Food and Drug Administration (FDA) earlier this week launched MedWatch - The FDA Safety Information and Adverse Event Reporting Program. An integral part of the new program is The Drug Safety Newsletter a quarterly publication that provides information on the findings of selected postmarketing drug safety reviews from FDA's Center for Drug Evaluation and Research.

The newsletter also provides information on important emerging drug safety issues and recently approved new molecular entities. FDA hopes the newsletter will raise awareness of reported adverse events, and stimulate additional adverse event reporting by healthcare professionals. The first issue of the newsletter contains reviews of the following products (information in the brackets are the most serious side effects)

• Rituximab (marketed as Rituxan): [Progressive Multifocal Leukoencephalopathy (PML)]
• Modafinil (marketed as Provigil): [Serious Skin Reactions]
• Temozolamide (marketed as Temodar): [Aplastic Anemia]
• Deferasirox (marketed as Exjade) -recently approved new molecular entity
  

Publication of this newsletter fulfills a commitment FDA made in its January 2007 response to the Institute of Medicine's (IOM) 2006 Report on The Future of Drug Safety - Promoting and Protecting the Health of the Public.

The newsletter is available at The FDA website.  Also, it will be sent electronically to those who subscribe to the Drug Safety Newsletter or to the MedWatch E-list.

To subscribe to this publication directly, go to the Drug Safety Newsletter section of the FDA site, enter your name and e-mail address in the appropriate fields, and select the "Join the List" button.  Hopefully, this new publication will inform consumers about the potential adverse effects and side effects of marketed prescription medications.

Until next time.....

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

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