How much does Big Pharma spend on: Marketing and Sales vs. Research and Development?

http://www.ritholtz.com/blog/wp-content/uploads/2015/02/big-pharma.png

Spot the outlier?

Would be interesting to find "... vs. Manufacturing, QA, and Supply Chain"

Can we draw any implications about these ratios and the effectiveness of patient outcomes per product (portfolio)?

 

Re: How much does Big Pharma spend on: Marketing and Sales vs. Research and Developme

Most of the marketing expenditures is in TV ads for these large companies that more than enough pays itself back and then some, while R&D is mostly bloated staff and general overhead

 

Re: How much does Big Pharma spend on: Marketing and Sales vs. Research and Developme

Only a scumbag could say that TV adds "pays itself back am then more". Joe Camel cigarette adds is positive return on investment when shown to teenagers as well.

C*cksucker.

 

Re: How much does Big Pharma spend on: Marketing and Sales vs. Research and Developme

Good Morning Novartians.

Interesting study report released by a Tier 1 institution across the Atlantic: University of York.

"Research by health economists at the University of York has, for the first time, estimated the effects of changes in NHS expenditure on the health of all NHS patients.

This research has found that the ‘threshold’ used by the National Institute for Health and Care Excellence (NICE) when gauging the cost-effectiveness of new drugs is too high. This means that the approval of new drugs is doing more harm than good to NHS patents overall and the NHS is paying too much for new drugs.

Currently NICE uses a threshold of £30,000 per Quality Adjusted Life Year (QALY is a widely used measure of health that combines length and quality of life) to gauge whether the health benefits offered by a new drug are greater than the health likely to be lost because the additional resources required are not available to offer effective treatments to other NHS patients. The research found that this threshold is too high because £13,000 of NHS resources adds one QALY to the lives of NHS patients.

This means that more harm is being done to other NHS patients when NICE approves more costly drugs. For example, the approval of a new drug that costs the NHS an additional £10 million each year would offer benefits of 333 QALYs (at the current NICE threshold). This research shows it would also lead to the loss of 773 QALYs for other NHS patients with increased mortality in cancer, circulatory, respiratory or gastro-intestinal diseases and reduced quality of life in neurological diseases and mental health (a net loss of 440 QALY for every £10m of additional NHS costs).

This research shows that the NHS is currently paying too much for new drugs because the amount the NHS can afford to pay for the benefits that new drugs offer is lower than previously thought. It also indicates the scale of the harm that has been done to other NHS patients of devoting £280m of NHS resources to the Cancer Drugs Fund in 2014/15 (a loss of 21,645 QALYs)."

https://www.york.ac.uk/media/che/documents/nice/NICE%20Threshold%20Press%20Release%20190215.pdf


Big Pharma is facing headwinds in the unsatisfied thirst for > 20% profit margins.
By the time all of this is over, we will look much different but much healthier. With a laser focus on the patients, we have the ethical responsibility to deliver our products at any price to those who have an unmet need.

 

Re: How much does Big Pharma spend on: Marketing and Sales vs. Research and Developme

Patients at the center of everything we do.
Big opportunity for JR, JJ, and EC to push for [r]evolutionary transformation of the FDA.
Alternatively, we can put McKinsey on task.



We didn’t have to search very hard to find FDA burying evidence of research misconduct. Just look at any document related to an FDA inspection. As part of the new drug application process, or, more rarely, when the agency gets a tipoff of wrongdoing, the FDA sends a bunch of inspectors out to clinical sites to make sure that everything is done by the book. When there are problems, the FDA generates a lot of paperwork—what are called form 483s, Establishment Inspection Reports, and in the worst cases, what are known as Warning Letters. If you manage to get your hands on these documents, you’ll see that, most of the time, key portions are redacted: information that describes what drug the researcher was studying, the name of the study, and precisely how the misconduct affected the quality of the data are all blacked out. These redactions make it all but impossible to figure out which study is tainted. My students and I looked at FDA documents relating to roughly 600 clinical trials in which one of the researchers running the trial failed an FDA inspection. In only roughly 100 cases were we able to figure out which study, which drug, and which pharmaceutical company were involved. (We cracked a bunch of the redactions by cross-referencing the documents with clinical trials data, checking various other databases, and using carefully crafted Google searches.) For the other 500, the FDA was successfully able to shield the drugmaker (and the study sponsor) from public exposure.

It’s not just the public that’s in the dark. It’s researchers, too. And your doctor. As I describe in the current issue of JAMA Internal Medicine, my students and I were able to track down some 78 scientific publications resulting from a tainted study—a clinical trial in which FDA inspectors found significant problems with the conduct of the trial, up to and including fraud. In only three cases did we find any hint in the peer-reviewed literature of problems found by the FDA inspection. The other publications were not retracted, corrected, or highlighted in any way. In other words, the FDA knows about dozens of scientific papers floating about whose data are questionable—and has said nothing, leaving physicians and medical researchers completely unaware. The silence is unbroken even when the FDA itself seems shocked at the degree of fraud and misconduct in a clinical trial.

...the FDA has a history of not notifying the public about the misconduct it finds. About a decade ago, the agency got into trouble over a newly approved antibiotic, Ketek. Inspectors had found extensive problems (including fraud) affecting key clinical trials of the drug. Yet the agency did its best to hide the problems from even its most trusted advisers. As David Ross, the FDA official in charge of reviewing Ketek’s safety, put it, “In January 2003, over reviewers’ protests, FDA managers hid the evidence of fraud and misconduct from the advisory committee, which was fooled into voting for approval.” However, when the reports of misconduct at one clinical site began appearing in the press—along with stories of liver damage and blurred vision associated with the new drug—Congress stepped in, demanding information from the agency about the fraud.

But even the Senate couldn’t wring key information about the misconduct out of the FDA. “Every excuse under the sun has been used to create roadblocks,” complained an indignant Sen. Charles Grassley, “even in the face of congressional subpoenas requesting information and access to FDA employees.” The head of the FDA, Andrew von Eschenbach, attempted to explain to Congress why the agency didn’t tell its advisory committee about the problems in the Ketek study: “After considering the fact that the investigation results were preliminary ... FDA decided to hold the Advisory Committee meeting as planned ...” without notifying the committee of the potential problems. But Rep. Bart Stupak quickly pointed to an email, which, he argued, contradicted von Eschenbach's testimony. “So either you are not being forthright with us, when I believe you are, but whoever is doing your work is trying to lead this committee down the wrong path.” And the correct path showed that site after site involved in study 3014, as well as other key Ketek studies, were tainted as well.

In the decade since the Ketek affair, it’s hard to see any change in behavior by the agency. On occasion, the FDA has even actively approved and promoted statements about drugs that, according to its own inspectors, are based upon falsehoods. At the end of 2011, the FDA learned that an audit of a Chinese site involved in a key clinical trial of a different anti-clotting agent, apixaban, had turned up evidence of fraud: Personnel had apparently been fiddling with patient records. Worse yet, the fraud appeared to invalidate one key finding of the study. Just three months earlier, the researchers running the trial proudly announced in the New England Journal of Medicine that there was a “significant reduction in mortality” among patients who took apixaban compared with those who took the old standby, warfarin. Alas, the moment you exclude the data from the Chinese fraud site, as per standard FDA procedure, that statement went out the window. Yet look at the label for apixaban—the one approved by the FDA after the fraud was discovered—and you read that “treatment resulted in a significantly lower rate of all-cause death ... than did treatment with warfarin,” backed up by the data set with the Chinese site included. In other words, the label is carrying a claim that the FDA knows is based upon fraud. In a written response to my questions on this subject, the FDA stated that, “The FDA extended the drug’s review period to address the concerns. However, the review team did conclude concluded [sic] that the data at that site and other sites in China did reflect meaningful clinical information; that was not what was considered unreliable.”

Again, this isn’t an isolated incident. I had previously encountered bogus data on FDA-approved labels when a colleague and I were looking into a massive case of scientific misconduct —a research firm named Cetero had been caught faking data from more than 1,400 drug trials. That suddenly worthless data had been used to establish the safety or effectiveness of roughly 100 drugs, mostly generics, that were being sold in the United States. But even after the agency exposed the problem, we found fraud-tainted data on FDA-approved drug labels. (The FDA still maintains its silence about the Cetero affair. To this day, the agency refuses to release the names of the 100-odd drugs whose approval data were undermined by fraud.)

And the FDA covers up drug-related misconduct in other, more subtle ways, too. For example, the agency publishes the canonical listing of generic drugs in the United States, known as the “Orange Book.” Prescription drugs in this book are often given what’s called a “therapeutic equivalence code.” This code is a two-letter designation that signals the quality of the scientific evidence that a generic is “bioequivalent” to the name-brand drug. The code “AB,” for example, tells pharmacists and physicians that there are solid scientific studies proving that bioequivalence. Another code, “BX,” signals that there isn’t sufficient data to prove the generic is bioequivalent to the name brand.

When the Cetero misconduct was uncovered, key bioequivalence studies for scores of generic drugs turned out to be worthless...

This, too, is a pattern of behavior rather than a one-off. In the past few weeks, another major Cetero-type case began to emerge—this time, having to do with GVK Biosciences, a firm in Hyderabad, India. The European Medicines Agency, the European equivalent of the FDA, examined more than 1,000 drugs in various dosages affected by GVK’s “data manipulations” and has suggested pulling 700 off the market. You can find the full list on the EMA website; to their credit, the Europeans are being relatively transparent as the crisis develops. Not so much on this side of the pond, alas. So far from the FDA, we’ve heard precious little, even though there are drugs on the U.S. market that rely entirely on GVK’s tests. In a written statement, the FDA admitted that there were some 40-odd drugs whose approval depended upon GVK-run studies. Which ones? The agency is keeping mum, as it did with Cetero and with other similar cases. However, the agency assures us that it inspected GVK's facility and found nothing to be concerned about; if the situation changes, “FDA will take swift and appropriate action to ensure that the drug products available to American consumers are safe and effective.”

Why does the FDA stay silent about fraud and misconduct in scientific studies of pharmaceuticals? Why would the agency allow claims that have been undermined by fraud to appear on drug labels? And why on earth would it throw up roadblocks to prevent the public, the medical community, its advisory panels, and even Congress from finding out about the extent of medical misconduct? The answers the FDA gives are fascinating—they show how an agency full of well-meaning people can do intellectual backflips to try to justify secrecy.

The most common excuse the agency gives is that exposing the details about scientific wrongdoing—naming the trials that were undermined by research misconduct, or revealing which drugs’ approvals relied upon tainted data—would compromise “confidential commercial information” that would hurt drug companies if revealed. This claim falls apart under scrutiny. The courts have ruled that when information is provided by companies involuntarily, such as the information that an FDA inspector finds, “commercial confidential information” refers to proprietary material that causes substantial, specific harm when it falls into the hands of a competitor. It doesn’t cover embarrassing peccadilloes—or misconduct that might cause bad publicity when word gets out.

Another excuse I’ve heard from the FDA is that it doesn’t want to confuse the public by telling us about problems, especially when, in the FDA’s judgment, the misconduct doesn’t pose an immediate risk to public health. For example, when my colleague and I asked the director of FDA’s Center for Drug Evaluation and Research why the agency wouldn’t name the drugs affected by the Cetero fraud, she told us that the matter “did not rise to the level where the public should be notified. We felt it would result in misunderstanding and inappropriate actions.” But even the most paternalistic philosophy of public health can’t explain why the FDA would allow drug companies to put data on its labels that the agency knows are worthless, or to fail to flag bioequivalence problems in a publication that is specifically designed for the purpose of flagging those very problems.

The sworn purpose of the FDA is to protect the public health, to assure us that all the drugs on the market are proven safe and effective by reputable scientific trials. Yet, over and over again, the agency has proven itself willing to keep scientists, doctors, and the public in the dark about incidents when those scientific trials turn out to be less than reputable. It does so not only by passive silence, but by active deception. And despite being called out numerous times over the years for its bad behavior, including from some very pissed-off members of Congress, the agency is stubbornly resistant to change. It’s a sign that the FDA is deeply captured, drawn firmly into the orbit of the pharmaceutical industry that it’s supposed to regulate. We can no longer hope that the situation will get better without firm action from the legislature.

The FDA wants you to take it on faith that its officials have the public’s best interest at heart. Justification through faith alone might be just fine as a religious doctrine, but it’s not a good foundation for ensuring the safety and effectiveness of our drugs. After all, the whole point of science-based medicine is to keep us from having to make a leap of faith every time we swallow a pill.

http://www.slate.com/articles/health_and_science/science/2015/02/fda_inspections_fraud_fabrication_and_scientific_misconduct_are_hidden_from.single.html

 

Re: How much does Big Pharma spend on: Marketing and Sales vs. Research and Developme

The most obvious and honest answer is NO.
Businesses have a convoluted and self-serving mechanism to calculate "research" costs...
Of course that has lucrative tax advantage to the employer.
It's a black hole.
Lots of "costs" in the continuum are clearly necessary, but the selfish and insane remuneration and profit taking is just SAD.
But clearly in middle and upper management everyone does MIGHTY MIGHTY well $$$$
BooHooo on "we need less regulation so we can invest in Science".....BULLSHIT.

 

Re: How much does Big Pharma spend on: Marketing and Sales vs. Research and Developme

Using the term "C*cksucker" to Big Pharma is an insult to C*cksuckers everywhere.