The Big Red Biotech Blog

Should FDA Panel Review A Bird Flu Vaccine Again?

In short, of course it should.  Science should be guided by data.  If you have new compelling data to examine, you should do it. Decisions can change if there is new data to support the change.  That should be self-evident to scientists and policy makers to my mind.

Should FDA Panel Review A Bird Flu Vaccine Again? // Pharmalot.

In this case, you are talking about purported new data that shows an elevated rate of narcolepsy being associated with persons who received the bird flu vaccine that contains a new adjuvant, AS03.  Supporters and detractors of review both rightly point out that the vaccine was approved as it battles a flu that to date has shown a 59% mortality rate in the 566 confirmed cases. The number of infected is small but the mortality is EXTREMELY high.  So I don't think we should focus too much on the original decision to approve -- it seems merited and was not capricious.

However, there is also new data developing that suggests an association with narcolepsy that is 14 times higher than what would be expected.  Couple that with the fact that narcoplepsy is considered to be an autoimmune disease manifestation, and there is also some suggestion that there might be elevated rates of rheumatoid arthritis (also autoimmune) in this vaccinated population.  It would seem prudent to check it out whether the adjuvant might be affecting this.

This seems to me to potentially be yet another very unfortunate fallout of the falisfied study linking autism to vacccination.  In that case, healthy children were placed at risk by parents choosing against vaccination against very common childhood diseases because of falsified data linking the vaccinations to autism. Scandalous really and extraordinarily damaging from a public health perspective, not to mention some unvaccinated individuals and other exposed naive populations. 

But let's don't overcompensate the other way and not look at new data coming in with regard to narcolepsy.  One fraud doesn't necessarily mean another is being perpetrated.  In this case, let's not go to sleep at the wheel without looking at the facts, and acting then on the merits of the case.

Posted by Bruce Lehr Mar 11th 2013.

Latest Shot in Comparative Effectiveness Battle

Memorial Sloan Kettering has announced that it will choose NOT to use one of the latest cancer treatments for colorectal cancer.  The drug?  Zaltrap.  Rejected because of the funky name? No.  Eschewed due to its cost? Yes, wholeheartedy says center representatives.

Rational Or Rationing? Saying No To A Cancer Med // Pharmalot.

Zaltrap costs on average $11,063 per month of treatment or about twice as much as the older drug, Avastin.  And, it has not proven to be any better than Avastin either. Doctors at Sloan argue that drugs need to prove themselves and they feel responsible for taking the financial consequences into account as well. Neither drug really knocks your socks off as they extend median life expectancy by a mere 1.4 months over standard chemotherapy.

So you can have Avastin for half the cost, with slightly fewer side effects and the clinical effect is very similar in terms of life extension.  Sounds rational to skip its use then, eh? 

No doubt this is the latest salvo in a battle that will rage on for some time -- especially if the Presidential race latches on to this issue.

Posted by Bruce Lehr Oct 15th 2012.

Do Pay Attention to the Data Behind the Curtain

Today, GSK announced it will part the curtain that previously obscured access to data from clinical trials.  In a move aimed at boosting transparency, GSK has pledged to make its clinical trial results available on a public website.  It has already published summaries of 4500 trials.

Now in a further, and unprecedented move, GSK will also seek to publish the results of all its clinical studies -- regardless of results -- in peer-reviewed journals. It will also create a system where researchers can access anonymous patient level data from clinical trials. This will enable researchers to examine data more closely and to combine data across studies to conduct further research. 

This is great.  Transparency is always good in my view.  It's nice to have a summary but even better to be able to see the raw data so you can do independent analysis and draw your own conclusions -- which may differ from those in a summary.  This is a step forward in openess and will put pressure on other Big Pharma peers to follow suit.

See Fierce Biotech and In the Pipeline for more details.

Posted by Bruce Lehr Oct 11th 2012.

Bayer Challenges Compulsory License In India

To no one's surprise Bayer has gone back to court to challenge the India Patents Office decision to award a compulsory license to the generic manufacturer Natco to make Bayer's patented anti cancer drug Nexavar.  The IPO invoked compulsory license rules citing Bayer's high selling price ($5500 per patient/month) as preventing most India patients from using the drug. Natco will sell its version for $175 or a 97% decrease.

Bayer Challenges Compulsory License In India // Pharmalot.

“We will rigorously continue to defend our intellectual property rights which are a prerequisite for bringing innovative medicines to patients,” a Bayer spokesman writes us. “The challenges faced by the Indian healthcare system have little or nothing to do with patents on pharmaceutical products as all products on India’s essential drug list are not patented.  Rather, the order of the Patent Controller of India damages the international patent system and endangers pharmaceutical research."

“This is the trivial argument Big Pharma has been making for years to cover the impact of its monopoly pricing policies,” writes Brook Baker, a professor in the Program on Human Rights and the Global Economy at the Northeastern University School of Law, and a member of Health Gap, Global Access Project. “Of course, there are other barriers to access, but does Bayer want to seriously argue that medicine priced 60 times more than the newly announced Cipla price doesn’t adversely impact access?"

Bayer unmoved, appears ready for an all out legal fight, you could say "they are going to the Madras" on this one.

 

Posted by Bruce Lehr May 7th 2012

13 Pharma, WHO & Gates To Tackle Tropical Diseases

The Gates Foundation announced that it is teaming with 13 of the largest pharma companies to find treatments for 10 neglected tropical diseases by the self-imposd deadline of 2020.  The Gates Foundation itself is pledging $363 M of the total $785 M earmarked for the project.  

Pharma, WHO & Gates To Tackle Tropical Diseases // Pharmalot.

Participating companies include, many of the world's heavy weight in drug development, many of whom have had at least some efforts for some time in going after these diseases.

• Bayer - Chagas disease
• Abbott, J&J, Pfizer, Sanofi, GSK, Eisai - lymphatic filariasis
• MSD - river blindness
• Sanofi, Bayer - sleeping sickness
• Gilead - visceral leishmaniasis
• GSK, J&J - soil helminthes
• Novartis - leprosy
• Pfizer - blinding trachoma
• Merck KGaA - schistosomiasis

Additionally, Abbott, AstraZeneca, Bayer, BMS, Eisai, GSK, J&J, MSD, Novartis, Pfizer, and Sanofi are working with the Drugs for Neglected Diseases Initiative (DNDI) to provide access to proprietary compound libraries to develop new drugs.  

"As an industry, we have the capabilies and the know-how and resources that can improve the state of the world, especially the developing world," said Paul Stoffels, worlwdie chair of the J&J pharmaceuticals business. 

Of course, others weren't quite as optimistic. Medecins Sans Frontieres (aka Doctors without Borders) argues that more research is needed and that these companies only spend a pittance on tropical diseases each year at $18.3 M -- compared to their oft cited figure of $1.3 B on a single approved drug.  See Fierce Biotech and the press release.

As Nike would say, "Just Do It".

Posted by Bruce Lehr Jan 30th 2012.

New Hope for Neglected Diseases

Here's an interesting post from the PharmTech Talk blog, speaking about a new UN initiative called WIPO Re:Search.  Is a forum for public and private organizations to share IP to help develop new drugs and vaccines to treat neglected tropical diseases, malaria and tuberculosis.  Sharing occurs through a public access database.

The National Institutes of Health as well as pharma companies like AstraZeneca, Eisai, GSK, Novartis, Pfizer and Sanofi have agreed to work with the group.

PharmTech Talk » New Hope for Neglected Diseases.

WIPO Re:Search members agree to license IP to researchers royalty-free in many, but not all, cases.  Royalty-free licenses are really extended to the very poorest countries of the developing world and not to all countires where these diseases are prevalent. 

For example, Chagas disease affects 21 countries in the America's but only Haiti (a non-endemic site) actually gets royalty-free status. In looking at the Chagas example (transmitted by black flies), it would seem the goals of WIPO Re:Search are laudable but there still seems to be room to get the bugs out in implementation.

Posted by Bruce Lehr Oct 31st 2011

 

The Cost Of Treating Cancer Is ‘Unsustainable’

The crux of this one?  New cancer treatments cost too much, address too few patients and provide too little benefit (in terms of survival) to be sustainable in the future -- given the economic drag developing in the system.

The Cost Of Treating Cancer Is ‘Unsustainable’ // Pharmalot.

The Lancet Oncology says we need to wave a magic wand to create a radical shift in policy to stop tolerance of "unfairness in access to affordable cancer treatment" and to deliver "fair prices and real value from new technologies."

Oh! Is that all?

Posted by Bruce Lehr Sep 26th 2011.

 

 

 

What Biotech Wants From Big Pharma Partners: Survey Says!?

Last month, Avalon's founder Kevin Kinsella did an interview with Xconomy where he stated that Big Pharma was engaging in more predatory tactics when approaching deal making with biotechs.  And, he claimed the behavior was getting increasingly worse over the last 5 years.

What Biotech Wants From Big Pharma Partners: Survey Says!?.

The In Vivo blog (above link) published a summary from a Boston Consulting Group survey that looked at biotech's desired behaviors from a big pharma partner in a deal.  It also named those Big Pharma players who were most admired by biotech in this regard.  The survey was performed with 100 respondents (out of 500) who were heads of business development or CEOs at biotechs. 

Roche and Merck emerged as the survey winners.  Roche won top honors in four categories:

• Deal structure flexibility
• Executive leadership
• Alliance management
• Manufacturing expertise

Merck led in five categories itself, including:

• Responsiveness
• BD/licensing group access
• Therapeutic areas of interest
• Control over development
• Post-deal success

Companies receiving honorable mentions in the survey included, GSK, Novartis, Eli Lilly, Pfizer and the biotech Celgene. 

BCG did not divulge the losers in the survey. They did note that Japanese companies images had improved drastically since the surveys conducted in 2003, 2006 and 2008.  It would be interesting to see if any of the winners were also companies that Kinsella was referring to in his comments above.  If not, it would be interesting to know who he was talking about and how these companies fared in the BCG survey too. There do seem to be some prominent names missing from the winners and honorable mention list.
Posted by Bruce Lehr March 26th 2011.

 

 

KV's 'outlandish' price for prenatal drug stirs hornet's nest

KV's pricing decision on its hormone therapy, Makena, has done it now.  Most of you are undoubtedly aware that the company successfully introduced an FDA approved version of the drug earlier this month under the Orphan Drug Act.  With its FDA approval and seven years market exclusivity provided by the act, KV promptly raised the list price to $1500 per dose from the prevailing rate of $20-30 that was being delivered from in-house compounding pharmacies.  The next sound you could hear was the hornet's buzzing!

Backlash builds over KV's 'outlandish' price for prenatal drug.

KV now has members of the US Senate, the FTC, the March of Dimes, the NEJM, the American College of Obstetricians and Gynecologists (ACOG), and the American Academy of Pediatrics in hot pursuit and calling for them to roll back their "outlandish" price.  The FTC, at the Senate's request, will investigate whether the company is engaging in "potential anticompetitive conduct".  Most of the above groups have contacted KV directly to lobby it to reduce its price - even its former allies, like the March of Dimes, has expressed shock and outrage at the pricing decision.

For its part, KV seems to have figured out that it made a serious error in judgment but may not have figured out what to do about it.  It does seem to know that it will be unlikely to get past third party payers at this point and all the other anti-constituencies that it has united.  KV issued a statement in its latest 10Q filing with the SEC acknowledging the risk it now faces with its pricing.  It noted the following issues it needs to deal with for its pricing of Makena:

• Ability to maintain certain net pricing
• Degree of success in obtaining 3rd party reimbursement - including government, privae health insurers, HMOs, insurance companies, and Medicaid
• Convincing medical practitioners to prescribe
• Degree to which compounding pharmacies continue to produce unlicensed alternatives

"The success of the Company is largely dependent upon these efforts and appropriately responding to both the media and governmental concerns regarding the pricing of Makena."

As noted by several commentators, the whole circumstance appears to have been created by KV receiving Orphan status and exclusivity for a product it did not discover, didn't fund clinical trial work on, and don't even manufacture.  Then it MADE an egregious pricing decision for which it is deservedly being criticized.  However, one must question why Orphan status was even a possibility on a drug that had been around for 50 years, was previously shown to work in this application.  KV added some benefit in producing it under GMPs but certainly did NOT create any clinical value to the patient or provider along the lines of a $20 to $1500 per dose increase.  That's just plain greedy. 

This type of action I hope will be considered by the Congress in lookng at the Orphan Drug Act.  The Act has been good generally but is clearly intended as a carrot for companies to produce novel treatments for diseases/markets that would otherwise be unattractive for their revenues -- unless conferred with exclusivity.  However, it was not intended to allow a company to take an old treatment - gain approval - and then exploit a pricing position under a regulatory monopoly.  With the law written as it is, there is nothing to prevent another company from doing the same in the future.  It wouldn't surprise me if someone was working on new (old) projects right now. 

 
Posted by Bruce Lehr March 26th 2011.

FT Chimes In on State of Pharma Industry

Here's a Financial Times piece that is fairly critical of the pharma industry that is likley appearing now in response to Pfizer's recent decision to cut back it R&D in Sandwich, UK and in Groton, CT.   It starts by remembering Merck and J&J in their more "glory years" period where both were very highly regarded from a business and ethical point of view.

PharmaGossip: Now the FT chimes in as well.

It then talks about how Big Pharma has changed to become less patient and more financially focused with negative consequences as a result. Some of these being the industry's seeming fascination with me-too drugs, drugs for minor ailments of the rich countries versus more glarign medical needs of developing nations, focus on marketing over development -- all of which appears to have driven the industry to be less successful and more reviled by the public - the sterling image of yesteryear being despoiled. The Times article claims the industry's response to these woes is to increase lobbying efforts to delay further sales/profits erosion.

The article concludes with this thought:

"When an industry is broken, the best business strategy may be to manage its decline." 

Ouch!  Let's resolve that we're not there yet, and with some retooling of the development model and government support with tax policy can spur innovation -- so that the indsutry can recapture its momentum and restore some of it lost luster.

Posted by Bruce Lehr Feb 9th 2011.

The Pharma Rogues Gallery

As follow up to the previous post, more than half of the fradulent behavior from Big Pharma falls on the shoulders of the Big Four Offenders as reported in the Pharma Times via a Public Citizen analysis of the statistics.

The four companies - GlaxoSmithKline, Pfizer, Eli Lilly and Schering -Plough - and they accounted for more than half of all financial penalties over the past two decades, paying $10.50 billion in fines collectively. The two largest fines ever assessed by the US government against any companies were against Lilly ($515 million) and Pfizer ($1.2 billion), both in 2009.

Can anyone say Patent Cliff (and poor following pipeline) as a motivator of criminal or ethically challenged behavior?

 

 Posted by Bruce Lehr December 20th 2010.

 

 

Say "It Ain't So, Big Pharma, Say It Ain't So"

I've written several posts this year about the ethical challenges that Big Pharma seems to be facing and failing!  The Industry as a whole certainly doesn't appear to be striving for the ethical high ground at the moment and 2010 may represent a real nadir in criminal and ethical failures.  Take a look at the link below to an article in the Pharma Times.

Article Pharma industry tops government fraud table in USA.

It seem that Big Pharma has now displaced the Defense Industry as the number one defrauder of the US government.  Who woulda thunk that could ever happen?  Didn't this used to be called the Ethical Pharmaceutical industry?  Wow!

 

Posted by Bruce Lehr December 20th 2010.

Merry Christmas! Big Pharma Naughty Not Nice

Increasingly Big Pharma has been caught with its hand in the regulatory cookie jar resulting in a rapidly increasing set of criminal and civil penalties as chronicled below in this post from PharmaGossip.

http://pharmagossip.blogspot.com/2010/12/merry-christmas-big-pharma-naughty-not.html.

 

 
Posted by Bruce Lehr December 19th 2010.

 

Drug Makers Distort Published Clinical Trial Record by NOT Publishing

According to the Pharma Times,  researchers at the German Institute for Quality and Efficiency in Health Care (IQWiG) report in the British Medical Journal that 74% of the data on patients who took part in trials of Pfizer’s antidepressant Edronax (reboxetine) have not been published until now, and that the published data on the drug overestimate its benefits and underestimate the harms.

Edronax has been approved for the treatment of major depressive disorder in many European countries since 1997, but doubts have been raised about its effectiveness in recent studies and the rejection of its US approval in 2001.  Published trials (26% of the data!), however, show a favourable risk-benefit profile for the drug.

IQWiG researchers led by Dr Beate Wieseler sought to assess the benefits and harms of Edronax.  They analysed the results of 13 trials, including eight previously-unpublished trials from Pfizer and found data on 74% of patients were unpublished. A further comparison of pubished and unpublished trials showed that the published data had overestimated the benefits of Edronax and underestimated harm.Their review shows that Edronaxas is “a striking example of publication bias” which can affect health policy decisions. 

They say that current regulations on the publication of trial results are insufficient and call for drugmakers to be required to publicly disclose data for all drugs - even for those which never get approved. In an accompanying editorial, BMJ editors Dr Fiona Godlee and Dr Elizabeth Loder warn that “the medical evidence base is distorted by missing clinical trial data” and call for “urgent action is needed to restore trust in existing evidence.”

Effectively the clinical literature is being distorted by omission and we're being misled.  IQWiG has described publication bias as one of the most important and dangerous sources of error in medicine. Not coincidentally, this echoes claims raised by Professor Donald Light that pharmaceuticals is a "market for lemons"

Three reasons cited by Prof. Light for the pharm industry's "lemon production" are:

• Developer companies in charge of testing their own drugs
• Legal protections that allow information about harms and effectiveness to be hidden
• Low bar for drug efficacy that must be met for a new drug to be approved

 Selective publication of results to suit a company's interests in getting a drug approved goes to point two (bold face) above and speaks to IQWiG's/editors of BMJ concerns as well.

Posted by Bruce Lehr October 14th 2010.

More on G-men Looking into Foreign Drug Bribes

Pssst - Hey foreign goverment want to sell my drugs?

The US Department of Justice (DOJ) probe into big pharma corruption in foreign markets came to light back in August.  Here is an update on this investigation from yesterday's WSJ.  According to the WSJ, Merck, AZ, BMS, GSK, Lilly, Baxter and Sciclone have all received notice that they are part of the investigation of possible violations of the Foreign Corrupt Practices Act (FCPA).  No charges have been filed yet and may never eventuate.

The FCPA makes it illegal for companies whose stock is traded in the US to bribe government officials in other countries to obtain business. This investigation is focused on events that have occurred in Brazil, China, Germany, Italy, Poland, Russia and Saudi Arabia (looks like we're one BRIC shy of a load) - some of the fastest growing global markets where presumably companies are trying to gain a foothold/market share and competition is intense.

Four types of violations appear to be the focus of the investigation:

• Bribing government employed doctors to purchase drugs
• Paying company sales agents commissions that are passed along to government doctors
• Paying hospital committees to approve drug purchases
• Paying regulators to win drug approvals

Well, it looks like we have everyone in loop except patients covered.  Maybe some couponing for them.

Additonally, some bribes may have been made to physicians to influence drug trial results. Astute readers probably note that anothergoverment concern of late is the increasing number of drug trials going to foreign markets.  This becomes problematic as the FDA has fewer enforcement and inspection resources to devote to that activity - certainly fewer resources than they think they need to do a good job. The Senate has a bill under consideration to step up FDA enforcement capability.

Lanny Breuer, the head of the Justice Department's Criminal Division, told drug-company executives last year that investigating foreign bribery in the industry would be one of his priorities over the next several years, given the size and growth of its overseas sales.  Here. Here.

 Posted by Bruce Lehr October 6th 2010.

 

 

 

Antipsychotic Drugs - Side Effects May Include Lawsuits Too!

In an article from the NY Times, really a corollary to a post I had a couple of days ago discussing whether "fines" for questionable behavior like off label marketing, the sad facts of how antipsycotic drugs have been cultivated and marketed are laid out. AND IT AIN'T PRETTY!

PharmaGossip: Antipsychotic Drugs - Side Effects May Include Lawsuits - NYTimes.com.

According to the Times, the new generation of antipsychotics has also become the single biggest target of the False Claims Act, a federal law once largely aimed at fraud among military contractors. Every major company selling the drugs — Bristol-Myers Squibb, Eli Lilly, Pfizer, AstraZeneca and Johnson & Johnson — has either settled recent government cases for hundreds of millions of dollars or is currently under investigation for possible health care fraud.  Wow! Ethical pharmaceutical industry, huh.

Well, at least we're cracking down and fining these companies for wrong doing. That must be working right? Well..........maybe not quite.  The industry continues to market antipsychotics aggressively, leading analysts to question how drugs approved by the Food and Drug Administration for about 1 percent of the population have become the pharmaceutical industry’s biggest sellers — despite recent crackdowns.

Lew Morris, chief counsel for the inspector general of the Department of Health and Human Services, says he is serious about bolstering government efforts to reform or punish drug makers for illegal sales of antipsychotics.  “The message we want to send to the industry is it’s not just the same-old, same-old,” he said in an interview.

Over the next year, the government is adding at least 15 prosecutors and 100 investigators to pursue health care fraud.  Since more than 1,000 False Claims Act lawsuits are still under way, most of them focused on health care and many on lucrative antipsychotic drugs, these new lawyers should have plenty to do for years, and years, and years.  Sadly. 

For that reason alone, critics say they think the industry still hasn’t gone far enough to change questionable practices.  I'd say so.

Posted by Bruce Lehr October 3rd 2010.

 

Big Pharma Absorbs $5 billion in fines! "The cost of doing business!"

Here's one from the excellent PharmaGossip blog that I must admit that I find to be sad and disturbing. This is a report of a study performed by The British Medical Journal and the Bureau of Investigative Journalism, City University, London

PharmaGossip: $5 billion in fines! "The cost of doing business!".

Effectively, we seem to have fostered a system whereby big pharma engages in fraud - usually off label marketing - as a standard business practice in order to hit market return expectations.  This would also include kickbacks and "entertainment" for physicians (KOLs) - a sum said to exceed $200 M in recent years.

In the last 2 years alone, 6 of the top 10 pharmaceutical companies have been fined for fraud in the US with a further 3 undergoing investigations. The total paid out has been $5 B in fines. (Of the top 10, only Roche remains untouched by US government).

Pharmaceutical fraud is one of the US’s top 3 “threats” says Sharon Ormsby from the FBI Financial Crimes Unit, because everyone is touched by these frauds (of the billions going into US healthcare, 3 - 10% is believed to be siphoned off into fraud — a large amount that could go to needy patients. Healthcare Reform anybody?

I would encourage you to follow the link and read the rest of the article for more in depth examples and discussion.  But it appears that we've institutionalized this behavior to an alarming degree and that it is in fact more cost effective for companies to just pay the fines and continue business as usual - as the proftis reaped far outweigh the financial penalties.

At the risk of moralizing further, I will refer readers back to a few other blog posts (see here and here) on related topics.  I do think we need to refresher course in focusing on patient welfare and getting back to the roots on which the industry was founded - which I firmly believe was NOT more profits at any cost.

Let's try to remember  that maximizing the "good" a  company does is related to greater profitability, equity and return on assets, and creates more shareholder value.  And it is the right thing to do!

 

 

 

Posted by Bruce Lehr October 2nd 2010.

 

 

Can't Anybody Here Play this Game?

With sincere apologies to Casey Stengel, recent manufacturing failures in pharma industry make this question every bit as pertinent as when it was formulated about the 1962 Mets.

Genzyme. J&J's McNeil. Abbott. Amgen. Not exactly neophytes to the manufacturing and quality control of critical products serving the healthcare market.  Yet all have experienced problems in their manufacturing resulting in recalls, and in some cases shortages, and illness.

What's more? Many of these instances have been marked by a seemingly leisurely attitude in senior management toward getting to the bottom of the issues.  Or worse, lack of transparency in dealing with the problem with the patient base - lack of availability information, dealyed or phantom recalls, and stonewalling regulators.

Results? Loss of consumer confidence or anger among patients who are without their needed medications.  Plant closings and job losses for those employees. Senior management resignations (albeit too little too late).  Proxy fights. Consent Decrees.  And even an acquisition attempt (which could go hostile) in play.

Like most things. It would appear that this would come down to fundamentals.  Companies need to go back to spring training and work on basics of attention to detail, institution and adherence to strong quality systems - but even more importantly a return to responsibility, forthrightness and a commitment to ethics at the top.  These are ethical businesses correct?

Posted by Bruce Lehr September 27th 2010.