Pharma Reform - Latest Comments

Re: Drug Company Spends $100 Billion But Not to Find New Drugs

LDL4350 — Wed, 16 Jul 2014 14:38:48 -0000

And here we are still facing Drug Shortages across the nation. - What Shame Pharma really need to put that money into supplying more drugs to patients(SMH)

Re: Is Big Pharma Manufacturing Expertise Becoming a Misnomer?

Mike Wokasch — Wed, 13 Feb 2013 18:02:32 -0000

Denise,
Thank you for your question. You may already know that several Big Pharmas (e.g., Sanofi, GSK, Novartis) are making significant investments in Africa already. As suggested in my post, multidisciplinary manufacturing expertise is required for consistent, high quality cGMP-compliant pharmaceutical manufacturing. While other issues may play a role (e.g., regulatory standards, regional law, and governmental stability) availability of the required expertise (not just trained technicians) may be the rate limiting factor for growing manufacturing operations in Africa. mike@pharmareform.com

Re: Is Big Pharma Manufacturing Expertise Becoming a Misnomer?

Denise L Harrison — Wed, 13 Feb 2013 09:59:45 -0000

I enjoyed your article. Good insight. Do you think big pharma will partner more with African pharma helping this region gain more pharma tech ability?

Re: Healthcare Reform Impact on Prescription Drugs

Mike Wokasch — Sat, 27 Oct 2012 14:41:30 -0000

Daniel,
I have written a number of blog posts addressing how pharma companies can market and sell in this evolving new healthcare market (just click on the marketing or sales tags). The biggest changes that have affected the traditional sales and marketing tactics are access to physicians (reps and pharma marketing are no longer considered important/credible/reliable sources of product information), more rigorous critical reviews for managed market formularies and subsequent diminishing role of physicians in product choice, healthcare reform, and regulatory/legal constraints. Any new strategies or tactics have to take these into consideration and should start by developing better clinical and cost benefit data to support any claims you intend to make about a product. mike@pharmareform.com

Re: Healthcare Reform Impact on Prescription Drugs

Daniel — Wed, 24 Oct 2012 18:20:12 -0000

Dear Mike,

I am a recent Emory graduate who is preparing for consulting interviews with topics related to the Healthcare industry. As a learner and a young person interested in learning about the future of healthcare in general, I fould your article extremely insightful.

I do have one question that I would like to better understand: You comment that, "Traditional sales and marketing will have less influence on product availability at the prescription drug plan level and even less influence on physician prescribing practices." What actions, then, can drug producers take to ensure their products get into the prescribed available streams of medications by doctors (becoming competitive for the future), given that non-performers will be phased out and traditional marketing by drug companies may be less relevant in the treatment selection process.

Many thanks!

Re: Why so many Surprising Disappointments from Pharmaceutical R & D?

Mike Wokasch — Tue, 28 Aug 2012 20:43:56 -0000

stacy,
Thanks for your comment. I believe that by the time a company gets to the FDA approval stage there should be no surprises, including what the outcome is going to be. You gave me an idea for another post. Thank you. mike@pharmareform.com

Re: Why so many Surprising Disappointments from Pharmaceutical R & D?

stacy — Tue, 28 Aug 2012 17:32:08 -0000

Its a shame when companies get rejected during the FDA approval process. They spend months or years working to end in failure. You have to keep moving forward and doing your best to abide with ISO requirements. Its all we can do.

Re: How to Stop “Off-Label” Marketing and Sales of Prescription Drugs

Mike Wokasch — Wed, 25 Jul 2012 13:40:50 -0000

Dr. Lennox,
You raise some interesting points. I believe your concerns about the "rip-off clone" is not necessarily a bad thing if it actually leads to a better drug, more effective and/or fewer side effects. Unfortunately, the innovator company rarely feels compelled to pursue these opportunities in favor of focused development on the known "lead compound." At the same time, if the follow-on compounds are merely "me-too" drugs, the only benefit to patients is potentially keeping prices of the innovator product at a reasonably competitive level. I don't believe this is an area that should be regulated but rather let the patent process and market determine the novelty and value. mike@pharmareform.com

Re: New Work Rules for Pharmaceutical Sales Representatives

Mike Wokasch — Wed, 25 Jul 2012 13:27:29 -0000

Vipin,
I'm not sure how you overcome your work situation, especially if it is the industry norm. If it is not the industry norm, you can always look to work for a company that will provide a better work situation for you. mike@pharmareform.com

Re: New Work Rules for Pharmaceutical Sales Representatives

Vipin Garg — Tue, 10 Jul 2012 13:16:08 -0000

In India pharma Rep are in the worst condition. No 8 hour working, no over time even MER, LTA is included in the package. Overburdened by paper work which is of no use and the job has lost the attraction. Lowest salaries amongst any industry. How to over come?

Re: How to Stop “Off-Label” Marketing and Sales of Prescription Drugs

Dr. Joseph Lennox — Tue, 26 Jun 2012 00:11:31 -0000

Mike,

I really like what you're doing here. The pharmaceutical industry has turned into a callous profit-driven machine that is insensitive to the human element unless such sensitivity has political value to make them appear "almost human."

Off-label promotion needs to be stopped because there's not enough research involved in determination of metabolic pathways involved in alternative therapeutic indications especially when such indications are potentially being treated by other drugs. There's not enough resources in any company to research the effect of their drug on other disease states, and whether use of such a drug might exacerbate symptoms. There's most certainly not enough resources to study drug interactions from people being treated for multiple conditions.

A very "innocent" example is Lyrica. Pfizer made Lyrica for the treatment of fibromyalgia, however many psychiatrists have been using it as an anxiolytic to avoid the use of benodiazepines. Interestingly, Lyrica is MORE addictive than benzodiazepines, and the withdrawal. Hence, psychiatrists have created "addicts" by using a drug for purposes other than it's evaluated therapeutic indication.

There's another are of the pharmaceutical industry that needs to be regulated, and that's the common practice of "rip-off clone" drugs. Enclosed is an article (1500 words) that details my point.

http://lennoxtutoring.com/2...

If you need to delete the link, I understand. I looked for an email address for you, however could not find it.

Please keep up the good work on this excellent blog. I would enjoy a chat with you some day.

Kindest Regards,
Joseph R. Lennox, Ph.D.

Re: Comparative Effectiveness and the SATURN study Comparing Crestor with Lipitor

jim frederick — Sat, 21 Apr 2012 11:54:16 -0000

I was put on Lipitor by my physician 6 years ago and had masive headaches including Migranes. He switched me to Zocor and I had a constant dull headache and felt a little "fuzzy" all the time. I tollerated that for a month. When I went back for a consultation with my Dr. he said I may have an intolerance for Niacin so he put me on Crestor 10mg. I have been on it every since with no side effects. My lowered my bad colesteral to normal levels and raised my good colesteral so much my dr thinks I work out a lot.

Re: How to Stop “Off-Label” Marketing and Sales of Prescription Drugs

Kimberly — Fri, 03 Feb 2012 03:57:38 -0000

That makes perfect sense. Well thought out and stated. Thank you!

Re: How to Stop “Off-Label” Marketing and Sales of Prescription Drugs

Mike Wokasch — Wed, 01 Feb 2012 22:44:58 -0000

Kimberly,
Thanks for the good question. I don't believe this has anything to do with stunting innovation. In no way is physician prescribing inhibited or limited in this scenario. I am merely proposing that physicians, patients, and payers assume responsibility and accountability for their choice to prescribe, use, or pay for an unapproved use. I feel this is fair and appropriate. It has been too financially rewarding, incentivized and encouraged by reimbursement, to keep Pharma Companies from engaging in "off-label" promotion. As I state, that doesn't make it right and Pharma Companies should not be promoting their products for unapproved uses. At the same time, it has been too easy for the government and patients to use "off-label" promotion as the basis for litigating to multimillion dollar awards and settlements despite the fact that three other entities (physician, patient, and payer) all made choices to use a product for the unapproved indication. It's almost as if Pharma companies are being blamed for forcing physicians to prescribe, forcing patients to take to the drugs, and forcing payers to reimburse for the unapproved use. Although Pharma Companies benefit from "off-label" use, they have no capacity to prescribe, to make patients take drugs, or to approve payer reimbursement. mike@pharmareform.com

Re: How to Stop “Off-Label” Marketing and Sales of Prescription Drugs

Kimberly — Wed, 01 Feb 2012 20:58:53 -0000

This would be very effective in stopping off-label promotion. The portion that has to do with promotion should happen tomorrow. I am, however, concerned that by restricting the ability of physicians to prescribe drugs as they see fit we could stunt innovation. What do you think?

Re: What can FDA really do about drug shortages?

Mike Wokasch — Thu, 03 Nov 2011 13:43:50 -0000

Ken,
Thank you for your comment. You raise two important issues. One is an appreciation for the expense of maintaining and fixing a prescription drug manufacturing process. The second is whether or not the government should financially subsidize the fix when critical medicines are involved.

Keep in mind that many of these products are generic drugs and generic drug companies run on very thin profit margins. Maintaining the facility, process, and quality system requirements to manufacture prescription drugs to cGMP compliant standards is expensive, even for generic drugs and especially for sterile injectable products. Fixing manufacturing or quality problems, even for easy-to-manufacture products, is not a simple or inexpensive process. Diagnosing the problem, determining a fix, and then putting in place a solution followed by validation (practice runs to get it right and prove it works consistently, run after run) all take expertise, money, and time. This can be further compromised by older facilities and outdated equipment or machinery. I’m sure many of the products on the shortage list also probably have complex processes (not easily or inexpensive to fix) for making either the active pharmaceutical ingredient and/or the final finished product.

Whether the government should help pay for these fixes to maintain a supply of critical medicines is more a political, philosophical issue. I personally see this as a market issue. If the market feels they are critical medicines and patients need them, the market and patients should be willing to pay a price that better represents their value. mike@pharmareform.com

Re: What can FDA really do about drug shortages?

ken — Thu, 03 Nov 2011 08:52:49 -0000

Very interesting post. But why couldn't the FDA work with manufacturers to address regulatory concerns and even work with potential suppliers (essentially in an "extension agent" role) to raise quality levels, without this necessarily increasing prices? If having a stable supply of high quality drugs is a public good that the market alone is not providing, which is the clear take-away from this posting, then it makes sense for the government to step in and help supply the public good. I realize that may be infeasible, politically, in an era where everyone is obsessed with deficit reduction (and particularly deficit reduction by getting the government to spend less), but it strikes me as reasonable.

Re: Comparative Effectiveness and the SATURN study Comparing Crestor with Lipitor

Mike Wokasch — Wed, 21 Sep 2011 21:33:30 -0000

Ron,
Thanks for your comment. Perhaps one of the greatest deficiencies of typical comparative effectiveness trials is that they are not designed to evaluate how individuals or even subgroups might benefit (or be more susceptible to adverse reaction) from one drug compared to the other. They look at how the general population of patients (the masses) might respond to treatment. This approach may benefit payers and patients for whom it makes no difference but it does not help patients (might even make it difficult for them to get the right drug or pay much more for the one that works for them) who might respond better to one compared to the other. mike@pharmareform.com

Re: Comparative Effectiveness and the SATURN study Comparing Crestor with Lipitor

Ron Miklos — Wed, 21 Sep 2011 18:48:40 -0000

I have been on both of these drugs and Crestor, for me, was far superior to Lipitor. I had side effects with Lipitor. Crestor raised my HDL and lowered my bad cholesterol to normal levels. Having sold pharmaceuticals, there is no such thing as one size fits all. There is a danger in going to a strict formulary and all these statins are not created equal.

Re: New Work Rules for Pharmaceutical Sales Representatives

Mike Wokasch — Thu, 15 Sep 2011 12:57:18 -0000

Yeoh,
Thank you for your comment. This is not about how to manage and motivate employees but rather the realities of the magnitude of change to expect if pharmaceutical sales representatives are classified as "non-exempt hourly " employees. Trust and empowerment are important in an employer-employee relationship but from what I have read there is little flexibility in the law when it comes to making sure hourly employees accurately record their time on the job and are paid accordingly. mike@pharmareform.com

Re: New Work Rules for Pharmaceutical Sales Representatives

Yeoh — Thu, 15 Sep 2011 01:59:17 -0000

This kind of regulations will greatly reduce the morale & productivity of Pharma Companies - trust & empowerment are two of the great factors in motivating an employee to churn out productivity & creativity in line with the Pharma code of ethics. A certain amount of freedom which is not abused, can boost up the morale & figthing spirit of field sales force rather than close scrutinity.

Re: Are Pharmaceutical Marketing and Sales Targeting Pharmacists?

Mike Wokasch — Wed, 24 Aug 2011 19:58:31 -0000

Eleanor,
I worked at Covance, a contract research organization similar to Quintiles. I feel contract research organizations are sufficiently independent and add significant value to the drug development process. These companies have matured over the past 30 years and now have expertise, resources, and capabilities beyond that that even found in many big pharmaceutical companies.T hey provide considerable staffing flexibility to biotech and pharma companies that need varying levels of preclinical or clinical development expertise and support resources at any one time. For many clinical studies involving thousands of patients, hundreds of clinical sites, and the need for global execution, contract research organizations are often the only option to getting these large complex studies done. mike@pharmareform.com

Re: Are Pharmaceutical Marketing and Sales Targeting Pharmacists?

Eleanor Ng — Mon, 22 Aug 2011 08:30:13 -0000

Thanks Mike for the excellent appraisal of what the future can hold for pharmacists.

I am a pharmacist from Melbourne, Australia and am humbled by the fact that the Australian government have thus far, stepped in the right direction for the future of patient focused care and for pharmacists alike. Please refer to Australia's improving, evolving 'Home medication review' system found on http://www.medicareaustrali... which I'm sure you are already aware of.
This in my opinion, is a leading example of how pharmacists can improve their chances of survival in the overcrowded market of pharmacists in Australia. It also can improve patient outcomes, adherence, and patient education, as my experiences in this field demonstrates this.

I am curious as to know your opinion on companies such as 'QUINTILES' which seem to have created a whole new industry supporting big Pharma companies and whether they are independent enough from big pharma stakeholders and whether they genuinely increase the number of drugs made available to patients in a time where the incidence of disease exceeds the number of new therapies approved and made available. Thank you.

Eleanor.f.ng@gmail.com

Re: New Work Rules for Pharmaceutical Sales Representatives

Game is over — Thu, 11 Aug 2011 20:51:32 -0000

The salient phrase in the orginal post is this: "not sales people or professionals exercising discretion or independent judgment".

When pharma reps became "sample droppers" and learned to read off a script they ceased exercising professional judgment. The legal departments, scared of lawsuits for off-label use, have limited the exercise of professional discretion. When your discretion is reduced to deciding which catering service to use for a physician office lunch, the game has fundamentally changed forever. Sad but true.

Re: New Work Rules for Pharmaceutical Sales Representatives

Kerry — Wed, 10 Aug 2011 14:40:58 -0000

The presumption in here is that pharma jobs will still be considered to be as worthy financially as they are now. Why does everyone assume that this is a job that will always be a $70K - $100K salary? I can see pharma also cutting salaries accordingly. And if you don't think what they are paying is enough, then you won't take the job. But there are certainly enough people out there, young and old, beginner or veteran, that will take a $50K/yr job, especially in today's economy, and given the number of sales rep jobs that have disappeared permanently.