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"SHIT Happens" "The Birth of Pharma"

October 29 2013 at 9:39 AM
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http://davidhealy.org/shit-happens/

SHIT Happens

A century ago, a distinction was drawn between the ethical pharmaceutical industry and the patent medicines industry. Ethical companies specified what was in their medicines, whereas the patent industry kept the details hidden.

The Birth of Pharma

The patent medicines industry flourished on the back of a promise that some Secret Health Ingredient in their Treatment (SHIT) would transform us. SHIT allied to the development of modern advertising and marketing gave rise to Pharma, then the most profitable enterprise on earth.

Driven by hope, or need or fear, millions flocked to patent remedies made by companies like Glaxo and Beecham and were injured as a result.  These deaths and injuries led to the first efforts at reform the 1906 Act that set up the Chemical Bureau, later the FDA. This Sunlight Act forced the patent medicine companies to spell out the ingredients on the label of their secret potions.

A tightening of the regulatory noose in 1938 that coincided with the development of the Sulpha drugs, the first of a series of Magic Bullets, led to an apparent triumph of the ethical industry over the patent industry. An industry that claims to be ethical, made of companies formed from mergers between companies like Glaxo and Beechams, is still trading on the glories of the 1950s and 1960s.

Pharma is Dead.  Long Live Pharma!

But the ethical companies have been body-snatched by Pharma. Its the formerly ethical pharmaceutical companies who now engage in the most sophisticated marketing and advertising on earth and make the greatest profits.

A modern medicine is made of a chemical and information. The hiding these days happens in the information domain with companies like GlaxoSmithKline indicted for misrepresenting the information component of their blockbusters

These modern drugs are also available on patent but in this case a patent means that in return for the sole right to manufacture a product a company should be completely transparent about the ingredients or processes involved so that the market develops to the benefit of all.

But far from doing this, we have recently had the specter of AbbVie supported by all pharmaceutical companies including GSK taking an action against the European Medicines Agencys (a European successor to FDA) policy of open access to clinical trial data.  AbbVie  specifically want to keep Adverse Event Data from their clinical trials of Humira hidden, with other companies seeking the same for their drugs.

When something goes wrong for someone on their drug, they want doctors and governments and the media to shrug and say Shit happens, rather than ask any questions about the role SHIT may have played in what happened.

SHIT

The current strategies companies are adopting to maintain their ability to have SHIT in their treatments by refusing access to clinical trial data was first trailed in November 2012 in Wont Get Fooled Again and a series of further posts.

Wont Get Fooled Again was immediately followed by Access to RxISK Data.  We called on anyone with a view to tell us what we should do with the data being generated by people reporting adverse events.  For instance if there was data on GlaxoSmithKlines Paxil Seroxat Aropax Deroxat what should we do vis-a-vis GSK?

Perhaps inspired by Arthur Shafers vigorous input saying we should have nothing to do with Pharma, there were more comments (73) in response to this post than to any other post ever put up on this blog.

A majority of respondents seemed to see some place for some dealings with pharmaceutical companies. Arthur held out.

SHIT Hits Anne

The second most commented on post on this blog (65)  has been Anne-Maries Out of My Mind: Driven to Drink.  This is a compelling portrait of how SSRIs in some individuals can trigger a life-destroying alcoholism.  The comments offer further telling accounts from others similarly affected that should leave no-one in any doubt but that SSRIs can cause alcoholism.

This led RxISK to come out and state just that that SSRIs can cause alcoholism.  We are the only organization or forum that has done so.

One of the surprises to date has been that so few lawyers or others who might be interested have picked this issue up.  Britains Daily Mail is full of stories of women being left by husbands because of developing alcoholism that make it clear the women are also taking an SSRI.

Once locked in a drink cycle no-one will believe you if you suggest it might be your SSRI causing the problem not your partner, not your doctor, not AA, not the probation service or the Courts, not the regulators.  As Lord Denning would likely have put it if given half a chance:

If their story is right, it is such an appalling vista it cannot be. People drinking after they go on SSRIs should be regarded as alcoholics and if need be should stay in jail rather than be freed and risk a loss of public confidence in the law and pharmaceutical companies.

Accessing RxISK Data

Anne-Maries case was written up and published in the International Journal of Risk and Safety in Medicine - http://davidhealy.org/wp-content/uploads/2013/10/2013-SSRIs-and-alcohol-IJRSM-803091338-002-14-Aug-2013.pdf']);" href="http://davidhealy.org/wp-content/uploads/2013/10/2013-SSRIs-and-alcohol-IJRSM-803091338-002-14-Aug-2013.pdf" target=_blank>HERE.

Following the publication of Anne-Maries article, we have had enquiries from two companies who make generic versions of paroxetine Ranbaxy and Nolem.  Both asked whether the paroxetine involved in this case was made by them.  These companies appear to be taking seriously their ethical duty to track adverse events and inform regulators. Whether they should just concern themselves with their version of paroxetine is a moot point.

We mentioned to each of them that we then had 31 other reports on Rxisk of SSRI induced alcohol problems 9 on citalopram, 3 on escitalopram, 4 on fluoxetine, 3 on duloxetine, 5 on sertraline, 6 on paroxetine and 2 on venlafaxine.  We have had many more since.

Somewhat to our surprise neither company came back asking for more details on any of the other cases, as to whether their drug might be involved.

But the really interesting omission has been the lack of interest from GlaxoSmithKline.  Anne-Marie began treatment at a time when most of the paroxetine used in the United Kingdom was manufactured by GSK.

So who is ethical in the ethical pharmaceutical industry?

It takes time to track down details.  Arthur should we or should we not hand over details like this?  Do we charge for the time involved in tracking them down?

 

- See more at:http://davidhealy.org/shit-happens/?utm_source=feedburner&utm_medium=email&utm_campaign=Feed%3A+DrDavidHealy+%28Dr.+David+Healy%29#sthash.UjIgZPwB.dpuf


 
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"SHIT Happens - 2"

November 1 2013, 11:16 AM 

http://davidhealy.org/shit-happens-2

SHIT Happens 2

SHIT stands for Secret Health Ingredient in Treatment see SHIT Happens.  In the early twentieth century SHIT was some supposedly secret magic chemical.  In the early twenty-first century SHIT is important information about adverse effects of a drug that has been kept hidden.

In SHIT Happens, we reported that RxISK has adverse event data on a range of GSK, Pfizer, Lilly and Merck drugs, drawn from patients and doctors within the USA and elsewhere.

Generic pharmaceutical companies have been in contact to find out more about these adverse effects in order to meet their regulatory reporting requirements. Branding companies like Pfizer and GSK have not.

A colleague in response sent this piece by John La Mattina from Pfizer in Pharma & Healthcare, Sept 3rd 2013. The tone we are poor misunderstood good guys seems part of the through and through branding that goes with branded drugs. This is fed through to the sales representatives in the field and the cleaners in the building so that everyone is singing from the same hymnsheet when in fact what is involved is an operation that comes closer to a final nail in the coffin of someone who has an adverse event than even the faintest concession by a branded company that their drug might be causing problems.

For more on this Branded tone, see the forthcoming GSKs Journey to Transparency.

Can Pharma Hide Side Effects Of Marketed Drugs In The U.S.?

At the end of my first year of running research at http://www.forbes.com']);" href="http://www.forbes.com/companies/pfizer/" target=_blank>Pfizer http://www.forbes.com']);" href="http://www.forbes.com/companies/pfizer/" target=_blank>PFE +1.72%, I drafted a year-end letter to send to all my colleagues thanking them for their hard work and dedication, and wishing them a happy and restful holiday season. As a matter of protocol, I ran the letter by the head of HR, who told me that I needed to change it. The reason was that, at the end of the letter, I said that everyone should turn off their computers, take a break from email, and relax with their families and loved ones. My HR head reminded me that some employees had to work over the holidays, specifically those whose job it was to monitor the reporting of any adverse events that might be reported for our drugs. While 99% of the R&D folks were on holiday, a small cadre of colleagues would be working over the holiday break. I changed the letter accordingly, both acknowledging and thanking those who played this important role.I share this story because most people dont have a clue as to the vigorous requirements put on pharma by the FDA for reporting a drugs side effects. In fact,  when I write about the pharmaceutical industry, particularly posts that support the value that the industry adds to healthcare, I will often get attacked that I am defending an evil empire. Many believe that the industry hides negative data on its drugs. The following is typical: Side effects should be monitored and updated and told to patients and doctors. Not hidden as they are right now.Actually, specific regulations exist as to how the industry must handle and report adverse events. To make sure that I had my facts right, I checked with a former colleague of mine in a pharma legal department who shared the following information. Pharmas reporting requirements are defined in the U.S. FDA Code of Federal Regulations (21 CFR 314.80). Essentially, a U.S. Drug Manufacturer (Marketing Authorization Holder) is required to report serious, unexpected, drug related individual case safety reports within 15 calendar days of initial receipt as well as to report any follow-up information within 15 calendar days of receipt of new information.

How does a company hear of an adverse event? There are two ways. First, within the U.S., physicians and other healthcare professionals can utilize the FDAs MedWatch Adverse Event Reporting System to report an adverse event seen with a marketed product. In addition, physicians can contact the manufacturer of the marketed drug directly by using  telephone contact numbers (toll free) and/or websites provided by the company as mandated by the FDA. Should a physician only report the adverse event to the FDAs MedWatch program, that information is then forwarded to the drug manufacturer.

This system is not perfect as the MedWatch Program is voluntary. Thus, a physician could be derelict in reporting an adverse event. There are currently no repercussions should a physician choose not to inform  the drug manufacturer of an adverse event seen with its product. However, there may be State, County or Institutional regulations (e.g., hospital standard operating procedures) that obligate healthcare professionals to report these events.

Every pharma company has a group in its regulatory division dedicated to tracking adverse events and duly reporting these side effects both internally as well as to the FDA. This work goes on every day of the year and is taken very seriously. Contrary to the views of some of my critics, side effects are, in fact, monitored very diligently.

RxISK Data GSK & Pfizer

For those of you concerned about the poor folk working Xmas Day and Thanksgiving in GSK and Pfizer, it is perhaps worth clipping out a section from the Access to RxISK Data post that ran last November to make it clear just how seriously Pharma tell themselves they take their duties.   (See also SHIT Happens and Wont get fooled again).

If Andrew Witty, John La Mattina or Neal Parker were to take a train tomorrow and I was sitting in the seat behind and was overheard mentioning a side effect I was having on one of GSKs drugs part of company mythology is that they are legally bound to report this to the regulator.

Here is Leigh Thompson then the Chief Scientific Officer of Eli Lilly being deposed by Paul Smith on this issue in 1994 for the Fentress trial in Louisville Kentucky after Joseph Wesbecker on Prozac shot dead 8 of his co-workers and injured 12 more before killing himself.

Q. The other day you said something that I have a question about. You said something about. employees calling adverse event reports in?

A. The rules under the DEN system that I put in place  was that any Lilly employee anywhere in the world that learns of any adverse event through any source, and Ive done it from cocktail parties and overhearing conversations, should in fact report to DEN within twenty-four or seventy-two hours, depending on where they are in the world. So, yes, we got a lot of adverse events, including ones I report because Ive literally called up DEN and said, you know, that I overheard a conversation in the hallway just now that somebodys wife was taking Ceclor and had an allergic reaction.

Q. Do you usually stop and ask for more information about that adverse event or do you just report what you overheard in a conversation in the hallway?

A. Depending on who the individual is, but, for example, you remember you showed me the document about that meeting of the expert opinion leaders that I had gone to wherever it was, I had another Lilly employee come to that meeting and follow me around so that that person could in fact report all the adverse events that I was hearing, so that I wouldnt have to do it myself.

I think it fulfills a regulatory requirement.. if you right now told me that you had heard of a patient who had taken one of our drugs and who had their hair turn blue, I will guarantee you that I would call DEN up within two days and that would be in the DEN database. And I may or may not ask you for more information, but I would identify you.

Q. So let me make sure I understand. You feel it is your absolute duty to report a conversation that you have overheard in the hallway, but you dont necessarily feel its your duty to report an issue raised by another regulatory agency and the analyses that were done by the drug company in response to that issue being raised?

A. Under the FDA laws and regulations, I think youve stated it correctly.

Writing to GSK about access to data

Against this background it seemed appropriate to alert http://davidhealy.org/wp-content/uploads/2012/11/Sir-Andrew-Witty.pdf']);" href="http://davidhealy.org/wp-content/uploads/2012/11/Sir-Andrew-Witty.pdf" target=_blank>Andrew Witty last March to the fact that we expected RxISK to start generating data on GSKs and other drugs mentioning that despite everything many still considered GSK to be among the more responsible pharmaceutical companies. http://davidhealy.org/wp-content/uploads/2012/11/GSK-Response.pdf']);" href="http://davidhealy.org/wp-content/uploads/2012/11/GSK-Response.pdf" target=_blank>GSKs response was to misattribute the remark that they were a responsible company to me and to thank me for this recognition, but to turn down a possible collaboration while in a follow up letter stating their full commitment to their regulatory obligations. [There's the Branding again].

We still havent heard from GSK or Pfizer despite accumulating large amounts of adverse event data in people taking sertraline and paroxtine and other company drugs See SHIT Happens.

There are endless ways to adhere to the letter of a regulation but not its spirit. This is why you hire lawyers.

The campaign for access to clinical trial data is about getting a proper picture of the effects of a drug.  Company efforts to restrict access to trial data is in fact more about restricting access to information about the hazards than about the relative inefficacy of treatment.  GSKs proposals to have an analytic plan and to underpin access and a Safe Haven Safe for GSK in which no-one will be able to snoop around and find adverse events they werent meant to find are all about restricting access to adverse event data.

Clinical trials are not the correct way to establish the hazards of a drug the diseases in which they are conducted commonly mask the hazards of treatment (The Spin that no Data can Overcome, Cri de Coeur, Once is Never, The Unbearable Lightness of Being.)

The best approach to hazards is to do what RxISK is trying to do. That is harness the real world experience of people taking a medication to get best quality descriptions of events as well as applying standard approaches to causality such as checking for dose response, challenge-dechallenge-rechallenge and other related methods. The best way to determine risk-benefit ratios is to ask doctors and patients what they think of the possible trade-offs between the effects of a drug as RxISK asks but clinical trials dont. We get both doctors and patients to look at the wider impact of an event in a persons life in addition to reporting on just the event.

Rarely in the Field of Human Communication..

In contrast the pharmacovigilance put in place by the branded pharmaceutical industry out seems aimed at frustrating reporting or in the event there are reports it seems aimed at ensuring that we get the most degraded possible descriptions of events with no accompanying details (See American Woman, American Woman 2).

This is an industry that has succeeded in building a culture in which even good descriptions of the effects of drugs are dismissed as anecdotes except of course for patients reporting stunning benefits on treatment.

An industry where Ian Hudson, then of GSK, now head of Britains FDA (MHRA), can get hundreds of reports of a problem like violence on Paxil-Seroxat and still say he has seen no evidence that Paxil-Seroxat causes any problems (See Burn in Hell).

This is an industry that somehow regularly fails to send reports of adverse events to FDA as per regulations as Neal Parkers AbbVie appears to have done (See Sharing the Yellow Stuff).

Rarely in the field of human communication has the reality of what happens on the ground been so at odds with what the powers that be proclaim.

This is probably not the way Andrew and John and Neal see it.  But they must know that branding is all about pimping things up to look good but to continue the metaphor above all making sure the glossy image doesnt fart.


 
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