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Category: Business of Medicine

Vaxil Cancer Vaccine Hardly a Breakthrough

I’m not going to exhaust too much research time on this. But I’ll address specifically the article claims.

Again, as with my answer to Are the hospitals known as The Cancer Treatment Centers of America really effective? I will give the company itself the benefit of the doubt, because this was not an official press release put out by the company. Instead it is an article posted in blog format by an non-medical/healthcare organization.

Still, here’s red flag #1:

“It’s a really big thing,” says Levy, a biotechnology entrepreneur who was formerly CEO for Biokine Therapeutics. “If you give chemo, apart from the really nasty side effects, what often happens is that cancer becomes immune [to it]. The tumor likes to mutate and develops an ability to hide from the treatment. Our vaccines are also designed to overcome that problem.”

Putting aside my bias against describing a cancer vaccine as “a really big thing” (this could be a language issue) — Levy, who is the company’s CFO (where is the chief medical / scientific officer? Medical director? Why aren’t they being quoted?) — attempts to describe the evolution of metastasis that then leads to a false claim (if he were in the U.S. governed by FDA’s mandates.)

There is no data from the company that suggests the vaccines were designed to “overcome that problem” — and which problem, exactly? The “immunity” problem? The “mutation” problem? The “ability to hide from treatment” problem? Each of these could be specific traits to a cancer cell, or according to Levy, would collectively describe one cancer cell. These can also be traits for either solid tumors or liquid tumors. But Levy is vague, when the investigational drug is being targeted for development against multiple myeloma, a blood cancer (liquid tumor.)

Red flag #2 Claim of “Breakthrough”

Is this “breakthrough” describing the idea of using a vaccine against cancer? No: Cancer vaccines aren’t a breakthrough. The immunotherapy concept has been around for decades.
Is this “breakthrough” describing the application of the vaccination concept against a specific cancer, namely multiple myeloma? No: As of November 15, 2011 there are 16 different cancer vaccine trials actively targeting multiple myeloma (Vaxil Bio’s trial is listed too).
Is this “breakthrough” describing a novel target? No: The MUC1 gene has been described back in 1984 when it was first observed in human breast carcinomas:
Is this “breakthrough” describing a particular characteristic of the investigational target? Maybe: According to the company’s website: “Unlike other vaccines which target the entire MUC1 protein or other domains, ImMucin does not contain any non-specific epitopes, which could dilute and disturb specific anti–cancer immunity. ImMucin™ was shown to selectively be expressed on tumor cells, thereby ensuring specific anti-cancer activity.”

In conclusion:

Hardly a breakthrough,
may be an interesting agent to add to the mix in a cancer that currently has multiple therapeutic options (including antibody-based therapies considered as “novel” agents — see,
with limited clinical trial involving more than 15 patients in one site

Free advice for the company: I’d save the big claims language until I see progress free survival and overall survival data…. because isn’t a true breakthrough grounded in patients getting the outcomes that matter the most to them — an acceptable balance between extended quantity of life with a reasonable quality of life?

Cancer Treatment Centers of America (CTCA) Effective?

[I wrote this originally as a response to a question asked by Quora by a Quora user. My response attracted the attention of an employee of CTCA, who engaged me in a debate that I felt was derailing, given that I have access only to what was PUBLICLY available. The employee then solicited the testimonial of a former patient to write a “non-answer” because she does not address “effectiveness” of this treatment center, only how wonderful she felt they were.]

1 Nov, 2012 My response is to the specific component of the question that talks about “effective”-ness, which in the oncology world tends to mean “survival rates.” I’m not talking bedside manners, or how nice everyone is, which are important for patient satisfaction of course, but is not a direct response to EFFECTIVE.

I was not discussing the treatment model, and since I have no conflict of interest (read: access to privileged data or have financial stake in the institution), I could only speak to what is available to me as a member of the general public.
12 Nov, 2011
I’ve seen many commercials for the Cancer Treatment Centers of America (CTCA) here in California. The commercials have one thing in common: comparing how the patient may have been treated (bedside manners) by oncologists elsewhere, versus how patients may be expect to be treated by oncologists at CTCA. I’ve seen 2 different commercials and both highlight how the patients were treated with more compassion and also had a good outcome (these patients survived long enough and are healthy enough to make these commercials.)

I’m sure you’ve already done the internet searches and read about the controversies with CTCA around their FTC settlement:

This was many years ago. Let’s assume for the benefit of this answer (since I’m not going to rehash what you can find searching for CTCA online), here’s the approach I took to answer this question, which asks about practices and treatments.

“What clinical trials are being offered or have been offered by CTCA, compared with other cancer centers?”

The rationale is that patients should expect standard-of-care cancer treatments by both CTCA and a comparator cancer center — but should also expect a substantive number of clinical trials offered by CTCA when compared with comparator cancer center — because this can be an indicator of “best practices” and “clinical options.”

I will compare CTCA with another for-profit treatment center, US Oncology (which has been acquired by McKesson Corporation in 2010).

As of 11/12/2011 a search on showed the following:

CTCA — 23 Studies total
US Oncology — 5928 Studies total

Compared with US Oncology, CTCA has significantly less # of studies total in “experience.” But this may simply be a function of tenure. If you’ve been around forever, then of course you’re going to have more “experience”, so let’s look at history:

CTCA was founded in 1988.
US Oncology was founded in 1999.

CTCA has been around 11 years longer than US Oncology. I’d expect CTCA would have a higher level of research activity. Let’s now look into specific research activities — back to the numbers — if I only include studies that are currently ongoing / recruiting patients:

CTCA — 7 studies total ( )
US Oncology — 1956 studies total ( )

Open studies means alternative treatment options for those patients who may not be able to tolerate “gold standard” treatment options or who may no longer respond / become refractory to the gold standard options. Here US Oncology wins with # of clinical trials available to patients.

Within the open clinical studies for CTCA, 2 of these trials aren’t treatments but rather nutritional/feeding interventions in patients with cancer. So technically, CTCA has 5 cancer studies open versus US Oncology’s 1000+. Also CTCA’s open studies are for solid tumors (breast, lung, liver, ovary) while US Oncology’s open studies span both solid and liquid tumors (leukemia, multiple myeloma). Of course, what actually matters is the patient’s cancer type as opposed to whether current options for studies are for solid versus liquid tumors.

Specific to CTCA, I looked into their page of treatment outcomes, since this serves as a major advertising point for patients: cancer patients want to go where they believe they may have an advantage when it comes to survival. I looked at their “statistics” on breast cancer and prostate cancer, but I looked at patient # that was used to come up with the statistic:

Prostate cancer: “61 advanced-stage prostate cancer patients who were diagnosed between 2004 and 2008 and who received treatment at CTCA for the duration of their illness.”
Breast cancer: “97 advanced-stage breast cancer patients who were diagnosed between 2004 and 2008 and who received treatment at CTCA for the duration of their illness.”

Immediately I have problems with these statistics:

Are you telling me that in 4 years’ time, you have treated only 61 advanced stage prostate cancer patients and 97 advanced stage breast cancer patients? I bet US Oncology treats that many patients within a 6 month period. Even if you have fewer centers than US Oncology, I take pause in these low #’s of patients included for analysis… until:
I look at this critical statement: “who received treatment at CTCA for the duration of their illness” — this means those who received treatment BUT DID NOT RESPOND WELL are likely EXCLUDED from the analyzed data. Why? Because patients with advanced cancer who are not improving at CTCA will likely go elsewhere to receive alternative treatments or get on a clinical trial. This means the data that was analyzed to show impressive survival rates may be SELECTED and therefore, BIASED.

In other words, I can’t believe these survival claims. It doesn’t mean that CTCA can’t be telling the truth, it only means that for the above, it is a selective sample and not necessarily the whole truth. Show me the # of patients who stayed for the duration of their cancer treatment at CTCA with the # of patients who LEFT for another treatment cancer for the duration of their cancer treatment and then we’ll have a more meaningful discussion.

Since I’d “deleted” the answer (it’s actually not truly deleted, but still resides on Quora if I choose to reactivate my account in the future) I wanted to include the comments from other (critically thinking) users. No doubt, my answer being featured in the Quora digest was what attracted CTCA’s “PR” damage control team. Hey, I used to work in pharma, I know all about tactics, and I also know from experience, this does not make the company / establishment more “credible”.
2013-01-06 01.06 AM22

Feb 27, 2013
One of my network colleagues happen to be using CTCA for her care and has this to say: “In 1 day at Cancer Treatment Centers of America they scheduled more diagnostics than what was possible at both ___ and ___ hospitals in months. I expect to know what’s what and options by close of business on Weds! This bodes well as I am not good at chewing cud!” — This is good feedback for the responsiveness of CTCA to this aspect of patient care.

Pharma Companies that Can’t Handle Comments Should Get Off Facebook, Good Riddance!

Jonathan at Dose of Digital talks about pharma’s fear of Facebook pages centering around 2 issues that pharma thinks require 24/7 monitoring: Adverse Events and negative publicity.

I hear the same excuse on why pharma companies are so scared to look at patient comments on blogs: adverse events.

I’m sorry, but adverse events are happening whether pharma companies are monitoring or not, and this is different from monitoring whether someone’s posting something “bad” about your company (newsflash: not everyone’s going to like you, better to expect it and have rules to address it than bury your head in the sand).

Adverse events are crucial for patient adherence and avoiding Facebook comments for fear of posts on AE is a missed opportunity for pharma to engage with patients in an issue that they all care about.

Patients expect drugs to work — rarely will patients want to get on a pharma page to thank the company for making a product that works. You may have a cancer patient who will do this if the company has gone above and beyond the call of duty to help the patient gain access to the drug that the patient otherwise cannot afford. But for the most part, patients have a “love-hate” relationship with pharma companies that is more “hate” than “love”, and I can’t blame patients for feeling this way.

What patients gripe about, and fear, and dread, are the adverse events.

Adverse events chip away a patient’s hope of getting better.

Adverse events erode a patient’s quality of life.

Adverse events make patients wonder, “would I rather stay ill, or deal with this horrible side effect?”

Then they look at companies avoiding discussion about something that is so key to their treatment experience, they naturally assume “profits before patients”. Never mind the realities of bureaucracy in adverse event reporting, I know it’s a bitch… the FDA knows it too.

That’s how pharma companies come across in their being so scared about Facebook.

Funny… I rarely recall pharma companies coming across scared when some of their sales and marketing teams find creative ways to fly under the radar to promote off-label. Somehow these companies are fine with breaking the law to “expand” usage of their drugs, but now they’re claiming they can’t deal with lack of guidance where Facebook pages are concerned.

Better companies pull their pages off Facebook if they are hard-headed about not allowing comments. Leave those who are more enlightened to get those patients’ eyeballs and possibly gain some goodwill.

Companies who want to control the message and behave hypocritically are doing the right thing by leaving Facebook: they aren’t adding value on the social network anyway.

Stop Pretending You Don’t Know, Pharma Companies!

I remembered years ago I was speaking to a Forest employee who told me how proud she was to be working at Forest because of how ethical the company and the CEO was.

That same employee was critical of me for talking to the WSJ about some of the less ethical practices that pharma companies have been using medical science liaisons – especially when all other quotes were positive – mine was the only one dealing with the abuse and misuse of the role. She felt that I should have used the media opportunity to “talk up” the profession.

I said that “talking up” the profession was what I’d done for all those years that I was running the MSL Institute. It’s time to “talk honestly” about what ails the profession so change can actually proceed.

I find what has happened with Forest Labs part of a lot of denial that some companies’ employees and executives experience when they see one thing but are told what they should be seeing.

If they oust the CEO, it will send a message to other CEOs at other pharma companies: “you’d better start hiring people underneath you who are capable of producing profit within the law, or you’ll pay for your bad hiring decisions.”

While it would be more poetically just to oust those who directly violated – firing the CEO is also part of the solution. The CEO’s job is to ensure that the people s/he has hired know how to create that ethical culture, not just talk a good talk but walking a different way when the feds aren’t watching.

After a while investors, who are always interested in protecting their investments, will catch on with the reality that golden parachutes are no longer a good deal.

Or is this too vicious of a cycle to ever catch up with the investors and the Street’s pocketbooks?

Pharma and Social Media: It’s Not About Controlling the Conversation, but Finding the Right Venues for Engagement

Now that Facebook Pages is to Marketing what LinkedIn Profiles is to Job Seeking – pharma companies are in pickle: Facebook is going to open up comments no matter what.

This means pharma companies can no longer restrict people from commenting on their Facebook pages.

Er…. DUH! Why is this big news? People get on Facebook to socialize – and not just to socialize – but to socialize in a mildly (or very) uninhibited manner. Facebook is MySpace done artfully and profitably, where we aren’t subjected to blinking starry page backgrounds or annoying music on auto-loop.

But remember why Facebook was created, and why Facebook has taken off with businesses – it is because when people are less inhibited, they are more suggestive, and more likely to click on links that businesses want them to click to buy stuff!

If businesses want stuffy and formal – there’s already a Facebook for that – it’s called LinkedIn.

I realize that it makes good sense for pharma to get its brands and company names out there. The problem is that when the public engages pharma, if they don’t ask about products, what would they want to engage pharma about?

[Assuming they aren’t interested in engaging pharma companies to ask, “why are you charging such high prices for drugs I need to save my life?”]

It’s akin to expecting a customer who drives a Toyota Corolla here in the U.S. not to engage the company Toyota to ask about the Corolla he drives. Unless that customer happens to work in an area that involves some business process, thereby predisposing the customer to want to ask about how Toyota “the company” works, customers often equate the company with the brands they use.

I understand that pharma industry supporters, including myself, would love if pharma can once again establish credibility with consumers by focusing on their support of disease state research and advancement.

Only another party’s already settled in that domain: they’re called physicians.

Physicians are typically seen as providers of support to patients in disease areas, from the consumer perspective. Let’s say I experience the symptoms of clinical depression – I’d naturally think, “I need to seek info from the doctors (once I learn more about this on the web)”.

I am not thinking, “I wonder what information GSK or Pfizer is providing in treating depression.” I’m not even thinking, “I wonder how Forest Laboratories or AstraZeneca are supporting R&D in depression relapse.”

But I may think in drug names, like, “I wonder if I should ask my doctor about Abilify, or Zoloft.”

[note: this would be an off-label use of Abilify, since Abilify is not approved for first-line use in treating depression, only as an adjunct to a first-line treatment if that treatment isn’t working as well as it should; it’s like a “boost”. But I use Abilify because I’ve been seeing so many ads on TV for it, and I honestly haven’t seen that Zoloft bouncy little ball in ages on TV.]

Thus there is first a cognitive hurdle that will not be easily passed. It is that diploma on the wall that garners the physician ‘credibility’, just as it is the commercial/business status that garners the pharma industry ‘lack of credibility’ when it comes to its participation as providers of information on the disease state, no matter how objective pharma tries to be.

In fact, even a recent survey of U.S. physicians had shown that they don’t want to pay for their own CMEs, yet they also won’t trust the CME content that is supported by pharma thereby making CME affordable (“free”) for them!

Logistically, the speed of Facebook and Twitter is exactly why Pharma should must hesitate.

People don’t go on FB/TW expecting a support-ticket time-frame (“slow”) response. They are on these platforms for just in time/immediate responses (“fast” “NOW!”). Otherwise, why bother? There are already online forums or patient info phone numbers for support-ticket speed “communication”.

It is not just about the platform, but the patient expectation that comes with the platform.

If you had ever engaged in a hashtag-driven Twitter chat, then you’d know how it’s next to impossible to follow every single conversation that comes at you in firehose fashion. Imagine then if there’s one or two patient complaints or problems amid the 20 other divergent discussions.

That’s what trying to retain “form” around a topical discussion may look like when Facebook comments are opened up for pharma.

[Lest any of us had forgotten – remember the “Motrin Mom” event, where a twitter indignation went viral and before the end of the weekend, the U.S. VP of Marketing at McNeil had to take that YouTube ad down? Try controlling THAT hashtag outbreak; I was there and saw how quickly it amplified.]

I’m 100% for increasing dialog between industry and consumers/public. Yet I think we can’t equate social media platforms the same, just as we can’t equate popular venues the same for medical education.

There are some social media platforms that are akin to a quiet, business like conference room.

Then there are social media platforms where people go for happy hour and unwind and engage in more personal conversations than business.

Then there are social media platforms where people go in expecting a brawl and in fact that’s why they showed up in the first place.

Pharma needs to identify these types of platforms and, rather than forcing or imposing artificial constraints by making everyone show up to a bar in a business suit.

The question Pharma needs to ask is, “is the purpose we intend to serve by showing up here feasibly achievable by the expectations of the crowd who will also show up?”

CME and Pharma: Doctors Want Support That They Can’t Trust

“Doctors want CMEs paid for them but can’t trust the people they want to help pay for their continuing medical education.” That’s how I sum up the below survey published by Archives of Internal Medicine.

Look at what the conclusion said: “Although the medical professionals responding to this survey were concerned about bias introduced from commercial funding of CME, many were not willing to pay higher fees to offset or eliminate such funding sources.”

If doctors are so concerned about ethics and bias, then they need to put up the money and pay for their own continuing education to stay current in their fields so that they can do their jobs. But based on “reality”, doctors are more concerned about their bottom-line and the survey suggests that their bottom-line trumps whatever concerns about bias they may have.

Clinician Attitudes About Commercial Support of Continuing Medical Education

Results of a Detailed Survey

Jeffrey A. Tabas, MD; Christy Boscardin, PhD; Donna M. Jacobsen, BS; Michael A. Steinman, MD; Paul A. Volberding, MD; Robert B. Baron, MD, MS

Arch Intern Med. 2011;171(9):840-846. doi:10.1001/archinternmed.2011.179

Background Pharmaceutical and medical device company funding supports up to 60% of accredited continuing medical education (CME) costs in the United States. Some have proposed measures to limit the size, scope, and potential influence of commercial support for CME activities. We sought to determine whether participants at CME activities perceive that commercial support introduces bias, whether this is affected by the amount or type of support, and whether they would be willing to accept higher fees or fewer amenities to decrease the need for such funding.

Methods We delivered a structured questionnaire to 1347 participants at a series of 5 live CME activities about the impact of commercial support on bias and their willingness to pay additional amounts to eliminate the need for commercial support.

Results Of the 770 respondents (a 57% response rate), most (88%) believed that commercial support introduces bias, with greater amounts of support introducing greater risk of bias. Only 15%, however, supported elimination of commercial support from CME activities, and less than half (42%) were willing to pay increased registration fees to decrease or eliminate commercial support. Participants who perceived bias from commercial support more frequently agreed to increase registration fees to decrease such support (2- to 3-fold odds ratio). Participants greatly underestimated the costs of ancillary activities, such as food, as well as the degree of support actually provided by commercial funding.

Conclusion Although the medical professionals responding to this survey were concerned about bias introduced from commercial funding of CME, many were not willing to pay higher fees to offset or eliminate such funding sources.

Will Technology Replace Pharmacists?

Maybe it can. But there are aspects of healthcare that can never be automated.

Yes, I worked in healthcare and consulted for one of the stakeholders, and I have seen the benefits of automation – reducing human errors, improving delivery efficiency.

But healthcare is a human profession, dealing with human beings and usually human beings who are sick, in pain, hurt, scared, and suffering.

Pharmacists are a member of the healthcare “human care team”, just as physicians and other healthcare professionals are part of that whole unit of caregivers and experts whose job is to focus on that one patient in front of them who is sick, in pain, hurt, scared, and suffering in some way. They know that one day, just like you and I will were we to live long enough or old enough, they and each one of us will be a patient one day.

So the point of pharmacy as a profession is the same in its foundation as the point of medicine as a profession, medical science (that branch of PhD research science dealing with human beings and human bodies in some way) as a profession, and any applied healthcare related business as a profession (regulators of industry, manufacturers of drugs, devices, and diagnostics) –

To care not just the human body but the human being.

Yes, you can get a machine to query for medicines that the patient is taking, whether there are supplements or drugs that may pose adverse interactions. You can print out sheets of information to get the patient to know how to take the drug, when to take it, what to watch out for… But the pharmacist with the human touch can get the patient to feel like he is being cared for, that his health and life are important, and that he matters. That can go a long way in gaining patient compliance and having a positive experience in healthcare.

This is something that we may improve with technology – but can never replace.

Other people’s take on this issue

Would You Cancel a Surgery if Your Surgeon is Getting a Kick-Back?

The specific question is about getting kickbacks as a surgeon using a medical device, and was originally asked on Quora. The explanation to the question (posted by the asker) said,

“The department of justice has investigated conflicts of interest, and the Pittsburgh Post Gazette has published on the topic. To quote from the gazette:

Payments to other Pittsburgh area physicians include:
• The Orthopaedic Group of Pittsburgh received $75,000 to $100,000 this year from Smith & Nephew, and two of its doctors, Ari Pressman and Allan Tissenbaum, received individual fees. Smith & Nephew reported paying the same range of fees to Carnegie Mellon University, and to Carnegie Mellon professor Dr. Jeffrey O. Hollinger, a bone tissue regeneration expert.

• Biomet has a relationship with the University of Pittsburgh Medical Center’s Department of Orthopaedic Surgery, through Dr. Freddie H. Fu and Dr. Christopher Harner, paying $75,000 to $100,000.

• DePuy’s largest payment went to Dr. Lawrence Crossett, a UPMC surgeon who has received $250,000 to $275,000. On Dec. 6, he’s scheduled to perform two knee replacement surgeries, which will be broadcast over the Internet by DePuy and viewed by doctors.

• Zimmer, the largest of the joint manufacturers, paid out the most to Pittsburgh doctors, $1.16 million through Oct. 31.”

Regrettably, this is a relatively small fraction of the total physicians, giving the impression that most physicians have these conflicts of interest. Fortunately, the department of justice’s investigation has helped curtail these conflicts of interest. Having said that, if you discovered the night before your procedure that your surgeon has such a conflict, would you proceed with your surgical procedure or would you cancel it? Assume that the procedure is elective, not emergent.

I think there are various caveats to the question being asked, and perhaps, a different way of asking the question that can help the patient make better decisions about whether to stay with the surgeon or find another doctor:

Questions that came to my mind were:

  • Does the surgeon opt to cut when there is no clear benefit to surgery or when another therapy would give as good of a result?
  • Does the surgeon opt for one device over another device and is this decision based on a kickback or is it based on clinical data that suggests a benefit for the patient’s profile?
  • Is the surgeon an inventor or co-inventor of the device?*

Conflict of interest comes to light when surgeon has mostly a financial incentive to choose one device or another or to recommend surgery over nonsurgical alternative if there is no clear clinical benefit or if the recommendation introduces new side effects to the patient.

The last point that I marked with * warrants discussion because this is not so “clear cut” a conflict of interest as the first 2 bullets. In devices the physician may be an inventor or coinventor and then licenses the technology or device to a company.

Even though the physician may have a conflict of interest – by receiving royalty payments for example – the physician is also the best expert on the technology that s/he has invented, so the choice to go for one’s own device may have less to do with a kickback and more to do with the physician’s belief in the invention’s efficacy/benefit.

Here’s a link to an article a while back (and how I got the “mostly royalties” impression) from WSJ when device companies had to post what they’d paid to orthos – although the asker rightly pointed that that the medical device company engineers are probably the majority of inventors to the technology rather than the MDs themselves.

Yet there’s also the argument made by Andy Lemke on Quora (in the comments section) that a doctor who serves as consultants to several companies must know his/her stuff since s/he is so sought after by device companies, so it’s not necessarily going to hurt that physician’s integrity in the eyes of the patient.

Why I Chose NOT to be a Doctor

I was once a premed.

I chose not to become a doctor because I wasn’t truly interested in the profession, it was something I felt I “had” to do or “should” do because I happened to major in biology. And being a first generation Asian-American there was also pressure from being a “Tiger Cub”: we have limited career options: doctor, lawyer, engineer. I suck in math and was good in biology. Guess which option I had?

In my undergrad classes I was among other premeds; many of them went in for the Money, the Prestige, for their Parents. But they will all talk about how much they love helping people/patients on their applications.

I did consider taking the MCAT and even paid for one of those “prep courses”, in case I changed my mind. But I knew my grades weren’t good enough, I didn’t have “connections”, and I wasn’t going to throw good money after a bad risk, especially when that money was already borrowed money via student loans. I went to grad school instead.

Then I started working in the healthcare industry, first working for the pharma industry. Maybe the nature of my work in pharma predisposed me to witness the doctor-industry relationship in a way that brought out some of the unsavory traits of the medical profession.

I saw some of these doctors up close – their lives (and lack thereof), their values (and lack thereof), their character (and lack thereof), bedside manners (and lack thereof).

We are constantly reading about how “evil” the Pharmaceutical Industry is and how they corrupt doctors and so forth – that gets a lot of coverage in the presses. Well, I’ve seen it from the other side: there are doctors who have become savvier businessmen than they are savvy clinicians and they are perfectly capable of manipulating drug companies to fulfill their personal interests. I’ve had doctors asking me for favors that I knew had nothing to do with improving patient care. I’m not embarrassed to admit that my first year of working in industry had almost completely destroyed the trust I used to have in doctors.

I saw the state of Managed Care and the “healthcare business” that has made doctors more busy with administrative work than taking care of patients. A HMO doctor once explained to me that he goes through each day making sure he breaks even by seeing 50 patients. He knows how much $ he gets paid per patient from the HMO. So he has to see a certain # of patients to stay in business. Depending on the patient’s condition, say the patient has a cold, he’d spend a few seconds with the person, and knowing that the patient would expect “something” for the visit, the doctor would write a prescription for an antibiotic just to get that patient out of the office, so he could see the next patient.

The medical profession was not something I’d ever wanted for myself if I did not have a deep-rooted passion and conviction about going into the profession. In fact, the medical profession is one that I would not encourage my child to go into, unless again, he expresses a serious conviction about becoming a physician. I actually have to be careful about my own prejudices – that I do not vehemently discourage my child from considering this profession. That would be as bad as the Tiger Mothers who force their children into the medical profession.

I know this puts me in the “outlier” group of Asian mothers. But then again I’ve always been an outlier.

FDA Has to Slow Down to Keep Up with Drug Companies

Steve Woodruff is hopping mad with the apparent gross inefficiency and indecision of the “guidance process” for pharma company promotional practices when it comes to social media, and I can’t blame him!

But I’m on the FDA’s side this time.

Let me say up front that I never liked how the FDA remains vague and slow in the past, it sucked when I was a pharma employee trying to figure out just what the FDA “wants”, but the FDA had long acted like a tripped out lover who has something in mind but we’re supposed to guess or better yet – read his mind.

But today I am much more forgiving of the FDA than I am of pharma company management.

I was looking at a recent run down of 2010′s lawsuits settled by drug companies and to say that I’m disappointed with industry’s continual hypocrisy is a gross understatement.

It’s one thing when you can say that you’re working toward implementation of compliance practices. It’s another when you take one step forward and 3 steps back as an industry in something as “common sense” as “don’t mislead the public” (in every which way that can be done via old media/new media).

For so many years whether as employee or consultant, I have heard company management say “Patients are our #1 concern! People are our greatest asset! We want to do the right thing!” in public forums and company meetings. Then I look at the actions that are motivated by incentives and hidden rules at companies.

I’m not surprised why the government keeps ramping up its prosecution arm. I get that pharma changes are slow, but this looks almost as if pharma wants to test how slow it can change.

I’m not surprised the FDA has to “slow down to keep up”.

I have read some of the recent untitled warning letters sent to pharmacos, and the violative actions from pharmacos. HAVE YOU READ THESE? Look at the list growing from year to year. And how the SAME CITATIONS KEEP COMING UP, AGAIN AND AGAIN.

If I had to cull through the sheer amount of garbage that pharmacos continue to churn out as sales aid, my resources would come up short as well.

It’s like, pharma companies can’t learn!

It makes me want to say, “come on pharmaco people, you guys come armed with MBAs and doctorate degrees, you have teams of lawyers…. SERIOUSLY? THIS TYPE OF VIOLATION – STILL?”

Or more accurately, maybe they just don’t want to learn.

Maybe it’s still a game to see how much money you can make when you push the envelope and offset the profits with FDA imposed penalties and fines.

Even when you slapped with a huge lawsuit costing you hundreds of millions of dollars, well you can act like this is the stock market and say if you earned more revenue than lose it as a liability of “market fluctuation or market conditions” you’ll still come out on top.

Meanwhile, patients lose, healthcare loses, and pharma employees who actually want to do the right thing when earning their keep lose.

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