The “publish or perish” principle of academia is certainly not a new one and is likely as old as scientific research itself. And, while persons who choose scientific research as a career are often motivated by curiosity and the desire to improve the human condition, they soon find out that academic research is highly competitive and oftentimes dominated by overly ambitious and egocentric individuals. I’m sure that most of you have been told that in order to excel your research must be published in the highest impact journal possible. This, coupled with diminishing research funding can place enormous pressure on individual researchers to gain a competitive edge via less than ethical (and possibly illegal) behavior.
To that point, there was an article in this Sunday’s NY Times that described a postdoc who intentionally sabotaged the efforts of a rising star in a cancer research laboratory at the University of Michigan. While this is only one incident, I do not think that it is the only example of intentional sabotage taking place in academic research laboratories. In fact, this recent incident brings to mind a candid discussion that I had with a prominent academic researcher many years ago. He confided to me and a colleague that he intentionally sabotaged a fellow postdoc’s work because he did not like his competitor and did not want him to get recognition for a discovery (BTW, this discovery led to a patent that made the researcher a very wealthy person).
There is no doubt that in present times, working in an academic lab can feel like working in a pressure cooker that is about to explode. That said, it is important to realize that you are not alone and that learning coping skills can be helpful in relieving stress and anxiety about future career opportunities and employment. However, there is never an instance, when cheating, fabricating data or intentionally sabotaging a competitor’s experiments is acceptable. In fact, any researcher who behaves in this manner ought to be called out, censored and disciplined for their actions.
We are living in uncertain times in which hypocrisy, lies and alternate facts are acceptable to large numbers of people. As scientists, we are responsible for facts and ”the truth.” Any deviation from this obligation is unacceptable. In the end, people always look to scientists and researchers for answers, solutions and hints of the truth. It is important that we do not succumb to today’s economic and political pressures and continue to be the purveyors of facts and “the truth.”
The paper details the emerging field of Cannabis-derived pharmaceuticals, the companies that are developing these products and an up-to-date review of US clinical trials that are being conducted to garner FDA-approval of this new class of therapeutics.
Check it out!!!!!!!!!
Until next time,
Good Luck and Good Job Hunting (there is a future in the Cannabis industry!)
Yes, you read the title of this post correctly. A Brazilian study, published in the Journal of Sexual Medicine identified that zoophila (having sex with animals) along with smoking, sex with prostitutes, being nonwhite and several other factors were risk factors for penile cancer.
The conclusions in the study were reached after Brazilian urologists’ surveyed 492 Brazilian men 18 to 80, including 118 who had penile cancer. Surprisingly, 171 of the men admitted having sex with animals. Of them, 44 percent had penile cancer whereas 31.6 did not. The incidence of penile cancer was not associated with the number of times the men had sex with animals nor was there any link between the species of animals involved including mares, sows, cows or chickens.
While the study does not show that sex with animals causes penile cancer, it certainly elevates the risk of developing the disease. One of the authors speculated that abrasions of the penis during sex with animals may explain the link. However, additional research will be necessary before a firm (pardon the pun) conclusion regarding the link between sex with animals and penile cancer can be reached.
Last week, the US Food and Drug Administration issued a press release lauding its approval of 35 new prescription medications in FY2001. According to the release 2011 was a banner year for drug approvals; being only surpassed in FY2009 when 37 new medicines garnered regulatory approval.
FDA detailed its accomplishments in a report entitled “FY2011, Innovative Drug Approvals” which touted faster approval times in the United States as compared with the FDA’s counterparts around the globe. Twenty-four of the 35 approvals occurred in the United States before any other country in the world and also before the European Union, continuing a trend of the United States leading the world in first approval of new medicines.
Among this year’s highlights:
Two of the drugs – one for melanoma and one for lung cancer – are breakthroughs in personalized medicine. Each was approved with a diagnostic test that helps identify patients for whom the drug is most likely to bring benefits;
Seven of the new medicines provide major advances in cancer treatment;
Almost half of the drugs were judged to be significant therapeutic advances over existing therapies for heart attack, stroke and kidney transplant rejection;
Ten are for rare or “orphan” diseases, which frequently lack any therapy because of the small number of patients with the condition, such as a treatment for hereditary angioedema;
Almost half (16) were approved under “priority review,” in which the FDA has a six month goal to complete its review for safety and effectiveness;
Two-thirds of the new approvals were completed in a single review cycle, meaning sufficient evidence was provided by the manufacturer so that the FDA could move the application through the review process without requesting major new information;
Three were approved using “accelerated approval,” a program under which the FDA approves safe and effective medically important new drugs quickly, and relies on subsequent post-market studies to confirm clinical benefit. For example, Corifact, the first treatment approved for a rare blood clotting disorder, was approved under this program
Thirty-four of 35 were approved on or before the review time targets agreed to with industry under The Prescription Drug User Fee Act (PDUFA), including three cancer drugs that FDA approved in less than six months.
PDUFA was established by Congress in 1992 to ensure that the FDA had the necessary resources for the safe and timely review of new drugs and for increased drug safety efforts. The current legislative authority for PDUFA expires on Sept. 30, 2012.
Maybe the agency can keep its streak alive before PDUFA expires next year!
After a five month-long series of very public and often acrimonious negotiations, it appears that Sanofi-Aventis and Genzyme may be close to deal that would enable the French drug maker to acquire one of the world’s largest public biotechnology companies.
According to the NY Times and a number of life sciences blogs, both companies have agreed in principle on a framework for a takeover deal. The major sticking point in the negotiations is Sanofi’s tender offer of $69 per share of Genzyme stock. Genzyme executives and industry analysts view the offer as “too low” and believe that a stock share price in the mid-70s is more reasonable and likely in the end. Another sticking point is the success of Genzyme’s leukemia treatment Campath (alemtuzumab, which is in clinical development to treat multiple sclerosis but will be marketed under the brand name Lemtrada if approved). Genzyme believes that Campath will likely be a winner whereas Sanofi executives are not so sure. Consequently, the deal will likely include additional payments to Genzyme if the drug meets or exceeds certain sale targets for either or both indications.
Persons with knowledge of the negotiations suggest that the specifics of a deal will likely be worked out of the next week or so. This is because, on Monday, Sanofi signed a nondisclosure agreement with Genzyme to conduct due diligence for the deal. Really? What has Sanofi been doing for the past 5 months?
The Genzyme deal is critical for Sanofi which desperately needs to quickly get into the biotechnology game, particularly in the areas of oncology and neurological disorders. Last week, Sanofi’s experimental drug to treat breast cancer, iniparib failed to meet clinical endpoints in a late stage clinical trial. Also, Plavix, Sanofi’s top-selling anti-clotting drug will lose patent protection in May 2012 (FDA recently gave Sanofi an additional six months of marketing exclusivity based on a newly awarded pediatric indication). Plavix is the world’s second best selling prescription medication.
I don’t know about you, but I hope that this deal gets done soon! From the outset, it was apparent to most life sciences pundits and industry insiders that Sanofi would prevail and ultimately acquire Genzyme. Unfortunately, Genzyme’s ongoing manufacturing woes provided Sanofi with an excuse to “lowball” its initial offers. And, surprisingly, Genzyme’s management team had the chutzpah and wherewithal to push back hard. The bottom line: it is a great deal for both companies—“Just Do It.”
It is no secret that Sanofi-Aventis is facing a steep “patent cliff” in 2013 when some of its top selling drugs, most notably Plavix, will lose patent protection. Some analysts contend that the company can lose as much as a quarter of its annual revenue because of generic encroachment on blockbuster brands. Sanofi is narrowing its business to three areas — diabetes, heart problems, and cancer — and is seeking partnerships and acquisitions.
This past June, Sanofi inked a $398 million deal with US-based Ascenta Therapeutics to gain access to two experimental cancer drugs that are in preclinical development. Later that month, the company purchased TargeGen a privately held US biopharmaceutical company focusing on oncology R&D. Two months later, Sanofi announced that it had entered into a partnership with the Belfer Institute of Applied Cancer Science (part of the Dana Farber Cancer Institute) to gain access to additional experimental cancer treatments.
Today, Sanofi announced that it had reached an agreement with Germany-based Merck KGaA to jointly study experimental cancer treatments. Both companies Merck will conduct early stage human trials of Merck’s MSC1936369B and Sanofi’s SAR245409 and SAR245408 experimental drugs. Under the terms of the agreement, each company will carry out an early-stage dosing test of the drug candidates. Sanofi will be granted a license to study the safety and effectiveness of the Merck compound when used with SAR245408. Merck will be given a license to work with Sanofi’s other medicine to study its use in combination with its experimental compound. Financial terms of the deal were not disclosed.
Yesterday, Sanofi announced that it had signed an agreement with Oxford University to conduct multi-phase clinical and translational research in oncology with INDOX, a network of cancer research centres established across India in partnership with the university’s Institute of Cancer Medicine five years ago. According to the terms of the agreement Sanofi-Aventis has agreed to provide financial support to Oxford University in managing the INDOX network of eight cancer research centres across India.
Based on this spate of activity over the past six months it would appear that Sanofi is executing its new long term strategic plan. Stay tuned for more news!
The recession is clearly taking its toll on the biotechnology industry and continues to force it to consolidate. Today, Celgene announced that it would purchase Los Angeles, CA-based Abraxis Biosciences, Inc for $2.9 billion in cash and stock to expand its cancer drug pipeline. The company hopes to "re-energize" sales of Abraxis’ only approved drug, the breast cancer treatment Abraxane, and also win approval for Abraxane as a treatment for skin, lung, and pancreatic cancer. Sales of Abraxane began to tank after Astra Zeneca terminated a marketing agreement with Abraxis in 2008. Abraxane is an injectable medicine that is approved to treat breast cancer in patients who have failed all other treatment options.
New Jersey-based Celgene, the maker of Revlimid (multiple myeloma, and one type of the bone barrow disease myelodysplastic syndrome) and Vidazas (acute myeloid leukemia and five types of myelodysplastic syndrome) expects to seek approval of Abraxane as a treatment for lung cancer early next year. Celegene also sells Thalomid, a modified version of thalidomide, to treat mutliple myeloma and certain forms of leprosy.
Abraxis Biosciences employs about 900 people. While no layoffs or job cuts were announced, don’t be surprised when they happen shortly after the deal closes later this year.
Pfizer’s acquisition of Wyeth was supposed to provide the company with expertise—that was sorely lacking—in biologics and biotechnology products. While it is too early to ascertain whether or not the Wyeth acquisition will “bear fruit”, today’s announcement that Pfizer is suspending all clinical trials of tanezumab, a monoclonal antibody treatment for osteoarthritis, suggests that the company may need more help than expected to develop new biological products. According to a statement, Pfizer’s immediate worldwide suspension of the clinical trials followed a small number of reports of tanezumab patients experience worsening of osteoarthritis leading to joint replacement.
Things have not gone well for Pfizer lately. Earlier this year the company abandoned late stage clinical development of an Alzheimer drug called dimebon that it had licensed from a smaller specialty pharmaceutical company. Also in 2010, Pfizer halted clinical development of Sutent for breast and liver cancer after it failed to meet principal goals in two Phase III trials. Finally, several years ago, the company killed late stage clinical development of a highly touted new cholesterol drug torcetrapib (Lipitor’ successor) after it failed to meet clinical endpoints in a pivotal Phase III trial.
Not surprisingly, Wall Street analysts are not particularly enthusiastic about Pfizer’s future. Many consider Pfizer to have one of the worst pipelines among major pharmaceutical companies. Also, many believe that productivity at the company is lacking in almost all therapeutic areas. In defense of the productivity of Pfizer R&D scientists (those who still have jobs), it is extremely difficult to remain productive or focused when major acquisitions e.g. Warner Lambert, Pharmacia and Wyeth occur every few years. As I have stated numerous times before, bigger isn’t always necessarily better. Here’s hoping that the Wyeth acquisition can rescue Pfizer from its current “death spiral” and return some value to its shareholders.
Earlier this month, Merck BioVentures, the company’s new division focused on developing follow-on biologics aka biosimilars announced that it was scuttling plans to develop MK-2578, a PEGylated version of erythropoietin (EPO); its first follow-on biologics candidate (someone should have mentioned to Merck that PEG-EPO is NOT a follow-on product but actually a NME that would require full regulatory approval). In yet another setback, this past week the US Food and Drug Administration (FDA) postponed a decision to broaden usage of its Gardasil human papillomavirus (HPV) vaccine to women between the ages of 27 and 45.
The company had submitted new data to agency and had hoped to hear by the end of June about the new indication for Gardasil; FDA will likely delay a response until the end of 2010. Gardasil is already approved to protect against some strains of the human papillomavirus, which can lead to cervical cancer, in girls and women ages 9 to 26. It is also approved to prevent genital warts in males of the same age. Merck has aggressively been trying to expand the indications for the vaccine to bolster sales. Gardasil revenue in 2009 was $1.1 billion, down from $1.4 billion in 2008 and $1.48 billion in 2007.
Decreasing sales have been attributed to high cost of the vaccine and concerns over side effects after vaccination. Also, some parents’ worry that Gardasil vaccination may suggest to teenagers that premarital sex is okay. Interestingly, while cervical cancer remains a risk among HPV-infected girls and women, a recent study found that only 34 percent of teenage girls ages 13 to 17 received Merck’s Gardasil human papillomavirus vaccine. Finally, sales of Cervarix, a competing HPV vaccine developed by GlaxoSmithKline, are beginning to cut into Gardasil market share.
Pharmaceutical giant GlaxoSmithKline (GSK) and MedTrust Online, an online oncology information site announced the development of CancerTrials App, the first free geo-locating oncology clinical trials application for the Apple iPhone and iPad platforms.
According to a press release, oncologists can easily find and share information about experimental therapies in clinical trials with their patients. CancerTrials App provides a quick search menu based on 12 common cancers and more advanced features that refine searches based on criteria such as gender, age, trial status and more. Once relevant clinical trials are found, results can be mapped relative to the location of the iPhone or iPad running the application. These features should help oncologists connect patients to appropriate regional and local clinical trials for which they may be eligible. Obviously, the app will help to bolster clinical trial enrollment in the oncology space.
While not a full blow geo-based social media platform like FourSquare,the Cancer Trials app is a step in the right direction and demonstrates the power of mobile medical applications and the potential of social media to improve clinical drug development.
CancerTrials App for the iPhone and iPad is the first release of the application that connects to MedTrust Online’s proprietary databases of oncology information. Other apps for RIM’s BlackBerry and Google’s Android operating systems will be released over the next several months.
Hat tip to GSK which has boldly gone where no other pharma company has gone before!