War on Counterfeit/Illegal Drugs Hobbled by Same Demons as Real War

War on Counterfeit/Illegal Drugs Hobbled by Same Demons as Real War

Pfizer Intelligence Uncovers $200 of Counterfeit Viagra In Manila Raid!

"Armed with a tip from pharmaceutical company Pfizer Inc., several dozen government investigators carried out a series of rapid fire raids one day last month on what were supposed to be the key suppliers of counterfeit drugs in the city [Manila]," reports the Wall Street Journal (read the story here).

"The net result of the raids, touted beforehand as likely to be one of the largest counterfeit drug busts in the city this year, was $200 worth of fake Viagra, Pfizer's erectile-dysfunction drug."

This intelligence gaffe reminds me of the Bush-era Iraqi weapons of mass destruction intelligence gaffe that propelled us to war in Iraq. I'm wondering if the "war on counterfeit drugs" is similarly based on faulty intelligence?

Another similarity between these two types of war is the unbridled optimism expressed by those in charge. "I think we are making a dent in the problem, but it's a slow process," said Scott Davis, senior director for global security in the Asia Pacific for Pfizer and a former special agent for U.S. Customs. Smells or sounds like victory, but it's no where near actual victory.

Here's yet another analogy: the war on counterfeit (or illegal) drugs seems to be as hobbled by rampant corruption of officials as is the war in Afganistan (or Iraq). In the case of the Manila raid, an owner of a couple of the target warehouses "bragged that he knew the NBI's [the Philippine's National Bureau of Investigation; i.e., the country's FBI] lead investigator on the counterfeit drug case and the deputy director who authorized the raid." After the raid turned up practically nothing, "the owner and the government agents walked a block away to lunch at Maxim's Tea House, a Chinese restaurant, according to people close to the investigation." That lunch probably cost more than $200!

It was interesting that the raiders found what they thought was counterfeit Cialis -- an ED drug marketed by Eli Lilly. Unfortunately, they did not have a search warrant for that illegal product, so no one was arrested.

It appears that Pfizer and Lilly did not share their intelligence data in this case, otherwise the NBI could have had a more inclusive search warrant.

This begs the question: Is the drug industry working together as allies in the war on counterfeit/illegal drugs? Are they sharing intelligence? Or is this also "proprietary" information that each company wants to keep close to its vest?

EU's EMA Plans to Open Up Proprietary Drug Trial Data to Outside Investigators

EU's EMA Plans to Open Up Proprietary Drug Trial Data to Outside Investigators

European Medicines Agency (EMA) -- the European drug regulator -- "is opening its data vaults to systematic scrutiny in a move that will let independent researchers trawl through millions of pages of clinical trial information," according to Reuters news (here).

This is big news depending on how EMA makes these large data sets available to outside investigators and which investigators are granted access. Reuters reports that the agency will host a conference in November to determine who has access to what and how fast. As I always said of the FDA, if an agency wants to delay something, its best bet is to hold a meeting to discuss it or sponsor research to study it.

The drug industry has long argued that the clinical data it presents to the FDA and other regulators as part of the drug approval process is proprietary -- ie, closely guarded trade secrets. But critics contend that important safety data about drugs is hidden from outside investigators and the data is critical for maintaining public health.

"It will make a huge difference to public health," said Peter Gotzsche, director of the nonprofit Nordic Cochrane Centre in Denmark, which carries out systematic healthcare reviews. "The pharmaceutical industry routinely exaggerates the benefits of its drugs and plays down the harms or hides them. By getting access to material held by drug regulators we may discover that many drugs are less effective than we thought they were and also more harmful."

In 2011, Gotzsche wrote paper titled "Why we need easy access to all data from all clinical trials and how to accomplish it." In it, he said "Calls for data sharing have mostly been restricted to publicly-funded research, but I argue that the distinction between publicly-funded and industry-funded research is an artificial and irrelevant one, as the interests of the patients must override commercial interests" (find the full text here: "Call for Easy Access to ALL Clinical Trial Data").

A case in point is Vioxx, whose harmful side effects once were secrets known only to Merck and the FDA.

"Europe used to be behind the FDA in terms of openness and transparency but now Europe is ahead," Gotzsche said. Will the FDA ever follow EMA's lead?

I doubt it. FDA has been very gun shy of the pharmaceutical industry, which pays over 60% of the agency's budget for approving drugs. Also, the drug industry has no qualms about taking the FDA to court to defend itself. Usually, the FDA is sued by pharma for limiting the industry's First Amendment right to free and open speech. In this case, however, the industry would argue that FDA has no right itself to "speak" freely about clinical data provided to it by drug companies.

UPDATE (7/16/2012): While the EU plans to provide access to "confidential" clinical trial data, the FDA is prohibited by LAW to do so. The Wall Street Journal reports that the FDA is monitoring some of its own employees who are suspected of leaking confidential medical device data to the press (read about this here).

The DOJ v Pharma Settlement Planetary System

The DOJ v Pharma Settlement Planetary System

The Department of Justice (DOJ) just released a commemorative poster highlighting the six most-recent multi-million dollar settlements that drug companies have agreed to pay for inappropriately, and in some cases illegally, promoting prescription drugs. The poster represents just the latest version of the "DOJ v Pharma Settlement Planetary System," which still has room for additional members (see unidentified objects in the poster).

Here's a description of the planets and how they were "discovered" as reported by ProPublica (here):

• The smallest "planet" in DOJ's System is AstraZeneca, which was fined $520 million to resolve allegations that it illegally promoted the anti-psychotic drug Seroquel. The drug was approved for treating schizophrenia and later for bipolar mania, but the government alleged that AstraZeneca promoted Seroquel for a variety of unapproved uses, such as aggression, sleeplessness, anxiety, and depression. AstraZeneca denied the charges but agreed to pay the fine to end the investigation. NOTE: The size of the AZ settlement "planet" is so small in comparison to the others in the System that many experts do not consider it a true "planet" at all. (The AZ planet was "discovered" in April 2010).
• Next is Merck, which agreed to pay a fine of $950 million related to the illegal promotion of the painkiller Vioxx, which was withdrawn from the market in 2004 after studies found the drug increased the risk of heart attacks. The company pled guilty to having promoted Vioxx as a treatment for rheumatoid arthritis before it had been approved for that use. The settlement also resolved allegations that Merck made false or misleading statements about the drug's heart safety to increase sales. (The Merck planet was "discovered" in November 2011).
• The fourth largest planet is the DOJ System is Eli Lilly, which was fined $1.42 billion to resolve a government investigation into the off-label promotion of the anti-psychotic Zyprexa. Zyprexa had been approved for the treatment of certain psychotic disorders, but Lilly admitted to promoting the drug in elderly populations to treat dementia. The government also alleged that Lilly targeted primary care physicians to promote Zyprexa for unapproved uses and “trained its sales force to disregard the law.” (The Lilly planet was "discovered" in January 2009).
• Next largest in size is Abbott, which was fined $1.5 billion in connection to the illegal promotion of the anti-psychotic drug Depakote. Abbott admitted to having trained a special sales force to target nursing homes, marketing the drug for the control of aggression and agitation in elderly dementia patients. Depakote had never been approved for that purpose, and Abbott lacked evidence that the drug was safe or effective for those uses. The company also admitted to marketing Depakote to treat schizophrenia, even though no study had found it effective for that purpose. (The Abbott planet was "discovered" in May 2012).
• Pfizer, which up until recently was the largest planet in the DOJ System, was fined $2.3 billion in September 2009, then the largest health care fraud settlement and the largest criminal fine ever imposed in the United States. Pfizer pled guilty to misbranding the painkiller Bextra with "the intent to defraud or mislead", promoting the drug to treat acute pain at dosages the FDA had previously deemed dangerously high. Bextra was pulled from the market in 2005 due to safety concerns. The government alleged that Pfizer also promoted three other drugs illegally: the anti-psychotic Geodon, an antibiotic Zyvox, and the anti-epileptic drug Lyrica.
• GlaxoSmithKline is currently the largest planet in the DOJ v Pharma Settlement Planetary System. GSK agreed to pay a fine of $3 billion to resolve civil and criminal liabilities regarding its promotion of drugs, as well as its failure to report safety data (see "GSK Guilty of Off-Label Marketing from 1999 to 2010: Will Pay $3 Billion Settlement"). This is the largest health care fraud settlement in the United States to date. The company pled guilty to misbranding the drug Paxil for treating depression in patients under 18, even though the drug had never been approved for that age group. GlaxoSmithKline also pled guilty to failing to disclose safety information about the diabetes drug Avandia to the FDA. (The GSK planet was "discovered" in July 2012).

Drug Ads & Coupons: Who's the Decider? The Patient, the Physician, or the FDA?

Drug Ads & Coupons: Who's the Decider? The Patient, the Physician, or the FDA?

The FDA is concerned that the use of sales promotions such as free trial offers, discounts, money-back guarantees, and rebates in direct-to-consumer (DTC) prescription drug ads "artificially enhance consumers' perceptions of the product's quality" while also resulting in an "unbalanced or misleading impression of the product's safety." To test whether or not this is true, the FDA will soon start yet another study focused on Rx print ads: "Effect of Promotional Offers in Direct-to-Consumer Prescription Drug Print Advertisements on Consumer Product Perceptions" (see Federal Register Notice archived here).

[I recently posted about another planned FDA study to determine if disease awareness information in branded ads confuses consumers. See FDA Concerned About Product (eg, Lyrica) Ads That are Too "Educational"]

The history of this study is long and mysterious. I first blogged about it 2006; read "FDA, Coupons, and Sleep Aid DTC Ads." Shortly after that the Federal Register notice regarding the study was "yanked" (see "FDA Backs Down on Coupon Study"). Also, the Advertising Age and Wall Street Journal articles cited in those posts can no longer be found in the archives.

In September, 2011, however, the proposed study re-emerged in the Federal Register (here). Whatever happened between 2006 and 2011 is anybody's guess, but I assume that the Bush era FDA leaders axed the proposed study when they learned of it. By September, 2011, these people were on the way out and the door was open again to propose the study anew.

Anyhoo, I want to focus here on comments that PhRMA made in response to the proposal. Alexander Gaffney (@AlecGaffney), Health wonk and writer of news for @RAPSorg, summarized the general attitude of PhRMA (see "US Regulators Move Ahead With Planned Study on DTC Marketing"):

In its statement to FDA, PhRMA wrote it was “concerned that the study, as currently envisioned, will not yield information that is relevant to FDA’s regulatory responsibilities to ensure that DTC advertising is truthful, accurate and balanced.”

“Although the study may provide interesting information about the effect of promotional offers on consumer attitudes toward a brand,” explained PhRMA, “it likely will provide little information on whether promotional offers create or contribute to false or misleading advertising, particularly under real-world circumstances or whether additional regulatory requirements are warranted.”

PhRMA: The Physician is the Decider
I dug a little deeper into PhRMA comments (here) and was surprised to learn that PhRMA's position is that "it is the physician, not the patient (my emphasis), who ultimately must decide whether the benefits of the advertised drug outweigh its risks for any particular patient." Thus, says PhRMA, "the risks of 'misperceptions' ... should be even lower [PhRMA's emphasis] for prescription drugs than for experience goods [i.e., a product or service where product characteristics, such as quality or price are difficult to observe in advance, but these characteristics can be ascertained upon consumption] because any potential misperception, of necessity, will be quickly corrected prior to use through consultation with the patient's treating physician."

This is a very paternalistic POV in this day and age of social media and patient empowerment. Actually, it is the old "learned intermediary" defense that the drug industry often raises (in the past, less so these days) to shield itself from blame when things go wrong.

FDA must respond to comments submitted, but I couldn't find a direct response to PhRMA's comments cited above. I did find, however, the following comments and FDA's response that addressed the issue of the patient-physician relationship generally:

(Comment 22) Two comments mentioned that the study does not assess how consumer perceptions of product risks and benefits are translated into a discussion with their health care provider. One comment stated that because these products can only be purchased after a discussion with a health care provider, the study be redesigned so that consumer perceptions are measured after a discussion with a health care provider.

(Response) We concur that this study does not address behaviors, such as how ad perceptions are translated into a discussion with a health care provider. As noted previously, one purpose of DTC advertising is to motivate consumers to engage in a discussion with their health care provider about health concerns. Another purpose, supported by research findings (Refs. 20 and 21), is to increase awareness of available treatments. DTC advertising does not exist solely in the confines of a doctor's office; rather, DTC advertising targets consumers outside of a doctor's office, with the goal of prompting consumers to ask their physicians about the product. In deciding whether or not to discuss a particular product with their health care provider, consumers presumably are engaging in some sort of judgment about the product being promoted. Therefore, clear communication of risks and benefits is needed for consumers before a consultation with a physician, and it is valid to measure these impressions.

"Shoe" Comic Strip Spoofs Pfizer's Chantix (unbranded) Side Effects

"Shoe" Comic Strip Spoofs Pfizer's Chantix (unbranded) Side Effects

My Sunday newspaper comics section prominently features the "Shoe" comic strip on the front page. It's a favorite of mine. Today's Shoe spoofs the side effects of Rx drugs -- specifically a smoking-cessation drug. Although it doesn't mention any brand names, Chantix is the only non-nicotine drug approved by the FDA for smoking cessation currently available by prescription.

Here's the comic, which I pinned on my "Fun Pharma Images" Pinterest board:

Source: shoecomics.com via Pharma on Pinterest

According to the Shoe web site "The strip's namesake, Shoe, is based on legendary North Carolina journalist Jim Shumaker, Jeff MacNelly's first newspaper boss. P. Martin Shoemaker is a grouchy, cigar-smoking, newspaperbird with a tough side and an even tougher other side."

Even tough birds, it seems, can suffer drug side effects. Shoe mentions "chest pains, bad breath and a hacking cough" as his main side effects. This is funny in context of the quit smoking indication but Chantix has been linked to a much more serious side effect: suicide. For more on that see "Chantix May Be More Dangerous Than Smoking!" and the chart below:

Source: pharmamkting.blogspot.com via Pharma on Pinterest

Of course, Shoe may be taking some other drug such as a generic version of Zyban.

The question remains: would Shoe be better off smoking his cigars or taking a medication to quit?

I'm not a cigar smoker, but I wouldn't inhale cigar smoke if I were. But there's the secondary effects of inhaling the smoke that's released into the surrounding air by cigars.

In any case, Shoe would be a terrible boss to work for whether he quit smoking or not!

Recipes 2 Go: Pfizer's LIPITOR-Branded iPhone App. Is It an Ad FDA Should Review?

Recipes 2 Go: Pfizer's LIPITOR-Branded iPhone App. Is It an Ad FDA Should Review?

I just learned that Pfizer has developed an iPhone/iPad app that promotes LIPITOR, the drug company's off-patent lipid-lowering drug. The app is "Recipes 2 Go." It is the first pharmaceutical app that I know of that promotes a prescription drug.

Here's what the promo screen on iTunes looks like (click on it for an enlarged view):

The description -- shown here in its entirety -- mentions LIPITOR and the FDA-approved indication, which is managing high cholesterol.

Is This an FDA-regulated Drug Ad?
My question: Does this iTunes page qualify as an prescription drug ad that must comply with FDA regulations regarding fair balance (ie, Important Safety Information or ISI)? If it does qualify, then it violates FDA regulations because the page does not include ANY fair balance or a link to the full prescribing information.

Did Pfizer submit this page to FDA for regulatory review? Did it submit the page to its own MLR (medical/legal/regulatory) people?

I downloaded the app to my iPhone and found the side effect/fair balance information plus a link to the "full prescribing" information on the very bottom of the "About Us" screen. Here's what the screen looks like:

Only when you scroll down to the next screen do you see the notice "Scroll down to see Important Safety Information," which appears about 14 screens further down! Whew! That's a lot of scrolling!

The multi-page End-User Agreement (dated April 20, 2012)  should be read carefully. For one thing, it states that "NO STATEMENTS MADE IN THIS SOFTWARE HAVE BEEN EVALUATED BY THE FOOD AND DRUG ADMINISTRATION."

To which I say, Why Not? The FDA should definitely take a look at this app and decide if it complies with regulations.

Because this app does not present the ISI where it can easily be found (and not at all on the iTunes promo page), I gave it only a single star rating on iTunes :-)

Janssen Uses Digital Storytelling, Animation to "Bring Prescription Medicine Labeling to Life." But Not iPhone or iPad Life!

Janssen Uses Digital Storytelling, Animation to "Bring Prescription Medicine Labeling to Life." But Not iPhone or iPad Life!

Have you ever seen those animated stories any one can create using a service called "Xtranormal?" According to the web site, "Xtranormal helps you create amazing interactive stories with a few clicks and a little imagination."

The following funny animation about medication adherence was created using Xtranormal Movie Maker by HealthPrize, a company that markets a drug adherence program that was featured Pharma Marketing News (read "HealthPrize Teams Up with RealAge to Improve Adherence"¹; use discount code hprze).



Basically, you create a script, choose characters, scenery, gestures, etc. and  "Ta-da! You're instantly an animator, poet, pundit, educator or comic. Couldn't be easier," says Xtranormal.


Janssen Therapeutics -- a division of Janssen Products, LP, which is part of Janssen Pharmaceuticals, which in turn is a Johnson and Johnson company -- is currently "piloting" a series of animations that remind me of Xtranormal scripted animations like the one above. The script for the Janssen pilot, however, comes from the patient information sheet that accompanies the prescription medicine PREZISTA® (darunavir), which is used in the treatment of HIV.

To enhance patients’ access to and use of this information, Janssen launched this pilot program -- called The PREZISTA Zone (here) -- designed to "transform the experience of exploring this information online through digital storytelling and animation."

Features include the story of Jacob, a man who has just been diagnosed with a "chronic disease" (ie, HIV infection), told through a series of seven animated clips that help illustrate sections of the Patient Information (read more about this here).

Unfortunately, showing you the animations embedded in this blog post is problematic because they were created with Adobe Flash. If you have a flash-enabled browser, you'll be able to view the "trailer" video created by Janssen. I have embedded that bit of flash code below. If, however, you are viewing the mobile version of this blog on your iPhone or iPad (two of the leading mobile devices used by physicians and by patients like Jacob), you won't be able to see the "trailer." You also won't be able to view any of the animations over on the PREZISTA Zone web site.




You can see why these animations remind me of "movies" created with Xtranormal.

The following screen shot shows Jacob's physician explaining the side effects of PREZISTA to Jacob using what might be an iPad (probably would be in the real world).

Too bad Jacob's physician can't show Jacob the relevant PREZISTA Zone animation. She could be attending other patients while Jacob watched the animation and then answered any questions he may have had when she returned. That would have improved her practice. But she has to go through the list of side effects just as if she were reading them from the patient information sheet. That's what it sounds like when watching this animation, which reminds me of how the characters sound in the Healthprize animation.

Of course, Jacob has a smartphone (most likely an iPhone), which he is seen using in the following frame where he is talking to his sister about how to store PREZISTA:

“As a physician, I know from experience that people tend to learn in different ways, and that can pose different kinds of challenges for patients trying to educate themselves about their medications,” said Bryan Baugh, MD, Medical Director at Janssen Therapeutics. “We designed The PREZISTA Zone to meet a variety of personal preferences for learning and interacting with online information.

Too bad Jacob cannot "learn and interact" with The PREZISTA Zone via his iPhone!

¹Healthprize is an advertising client of Pharma Marketing News but I have not been paid to mention Healthprize in this blog post.

New Victoza Prescriptions Flatten After Novo Signs Deal with Paula Deen

New Victoza Prescriptions Flatten After Novo Signs Deal with Paula Deen

New prescriptions written per month for Victoza -- diabetes treatment sold by Novo Nordisk -- have leveled off just after Novo signed on celebrity chef Paula Deen as a spokesperson. Prescriptions for the drug were rising steadily for a year and a half prior to that.

The two events may be coincidental (and the flattening may be temporary), but interesting nevertheless because it puts a hole in the theory that the return on celebrity endorsements of pharma products is worth the investment.

The Victoza Rx data comes from a chart I found in the petition filed by Public Citizen with the FDA that asked the agency to withdraw Victoza because of increased risks that patients may developed pancreatitis, serious allergic reactions and kidney failure (find the petition here).

The chart shows a plot of "Number of Prescriptions" of Victoza (liraglutide) versus Byetta (exenatide), a competing drug marketed by Amylin (see below):

It appears that the number of (new) prescriptions written per month has leveled off at about 150,000 -- a number that has not increased since about January 2012 when Novo announced that Deen would be a spokesperson (see "My Bad! Paula Dean Shills for Novo Nordisk, Not Novartis").

In its petition, Public Citizen states "As can be seen by subsequent FDA safety alerts issued for acute pancreatitis, thyroid toxicity, and kidney failure over liraglutide’s first year and a half of marketing, warnings have not succeeded in preventing serious adverse reactions. This is especially unfortunate because diabetics are already at increased risk for pancreatic and kidney toxicity. ... The number of prescriptions for liraglutide has been steadily rising, putting increasing numbers of patients at risk of adverse reactions to this drug. The increase in adverse reactions is seen in the continuing reports in the FDA’s database, making it clear that the FDA’s use of warnings is not sufficient protection."

Public Citizen, however, does not report that based on post-marketing data, BYETTA has also been "associated with acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis" according to the safety information that is part of its "package insert."

A couple of questions:

1. Will this new focus on Victoza safety information scare Paula Deen? 
2. Can she discontinue taking Victoza if she felt it was necessary or would her contract with Novo prevent her from doing that (she does take other medications to control her diabetes)?

Beware of Subtle Changes to Social Media Sites that Can Impact Your Brand; e.g., Novo's Levemir

Beware of Subtle Changes to Social Media Sites that Can Impact Your Brand; e.g., Novo's Levemir

Keeping up with all the changes implemented by social media sites such as Facebook and Twitter can be a challenge for anyone. But it is especially important for pharmaceutical marketers to understand how such changes can impact their use of these sites and potentially get them into trouble with the FDA. An example of this was Facebook's new policy about comments and the implementation of Timelines. I have covered those issues by interviewing experts (listen, for example, to these podcast: "Facebook Timelines for Brands: The Implications for Pharma Companies" and "Pharma Facebook Commenting Changes: The Final Story").

Some changes, however, are virtually unannounced and may go unnoticed by brand teams. Twitter, for example, has made some changes to how things are displayed on its website when people are viewing accounts like Novo Nordisk's @racewithinsulin Twitter account. This is a fully "branded" account that features a celebrity endorsement of Levemir, Novo's long acting insulin used to treat diabetes. It's tag line is: "Racecar driver Charlie Kimball partners with Novo Nordisk to prove his high performance career is possible with insulin."

The "Race with Insulin" branded Twitter account is old news (listen to this podcast "Novo Nordisk's Race With Insulin Campaign: It's Not Just About Twitter"). What is new, however, is how information is laid out on the screen. Here's a screen shot (click on the image if you need a better view):

What I noticed is that the box that provides the "fair balance"/safety information is partially hidden by Charlie's tweet stream. I commented previously how this information is virtually impossible to read even when it is fully visible (read "Can You Read This Fair Balance on Race With Insulin Twitter Page, or Is It Just Me Having Problems?"). Now, however, it is even impossible for people with perfect eyesight to read fully.

No matter how wide I pull the screen, the safety information is blocked by the tweet stream. I also cannot scroll down to bring the bottom part of the safety information into view because that info is a static image in the background and only the tweet stream middle section of the screen scrolls up and down.

Novo Nordisk has changed the background image since the last time I visited the @racewithinsulin site. Part of that change was to move the safety information further down, which has lead to the second problem I noted above.

The first problem, however, is likely due to the new design implemented by Twitter. Novo Nordisk has not updated the background image to be compatible with this new design.

It's possible that the FDA may look at this branded site and determine that it violates regulations because the display of major safety information is not fully part of the branded message, which clearly is that Levemir is used for the treatment of diabetes and that you can live a "high performance career" with Novo's brand of insulin.

Of course, the FDA would have to read this blog post to learn about this.

Medical Device Marketing Don't Need No Stinkin' ROI!

Medical Device Marketing Don't Need No Stinkin' ROI!

"Standards for devices exist, they just don't make sense," industry critic Dr. Diana Zuckerman, president of the National Research Center for Women & Families, said in a Consumer Reports release (also read this CBS report "Investigation: Most medical devices implanted in patients without testing"; see video below).

"An investigation by Consumer Reports, which included interviews with doctors and patients and an analysis of medical research and a device-safety database maintained by the FDA, shows the following areas of concern:

• Medical devices often aren’t tested before they come on the market. “What they’re doing is conducting clinical trials on the American public,” says Dan Walter, a political consultant from Maryland. His wife was left with heart and cognitive damage from a specialty catheter, cleared without testing, that malfunctioned during a procedure to treat an abnormal heartbeat.
• There’s no systematic way for the government, researchers, or patients to spot or learn about problems with devices. “A coffeemaker or toaster oven has a unique serial number so if a problem is found, the company can contact you to warn you. Your artificial hip or heart valve doesn’t,” Zuckerman says. “Your doctor is supposed to notify you of a problem but may not be able to if he has retired or passed away.”
• Without major changes in the system, there’s not much that patients can do to protect themselves.

According to Consumer Reports, the majority of medical implants are not tested to make sure they are safe. Most of the time device manufacturers only need to pay the Food and Drug Administration (FDA) a fee of about $4,000 with minimal testing in order to get approval for marketing. Compared to drug approval, this is a walk in the park.

In fact, sometimes device manufacturers bypass this minimal approval process altogether as did Johnson and Johnson's Ethicon unit (see "J&J Marketed Medical Device Without FDA Approval").

Not only is the approval of medical devices by FDA more lax than the process used to approve drugs, medical device marketing is worlds apart from Rx drug marketing as I learned from a presentation made by a Medtronic marketing VP. The presentation focused on a case study of a marketing campaign for the Prestige Cervical Disc.

That case study showed that out of an estimated 5 million spine surgery candidates (patients) in the US, Medtronic only needed to capture 125 of them to break even on a very successful marketing campaign that reached 6.2 million local TV viewers, 80.5 million radio (especially satellite radio) listeners, 4 million print readers, and 73 million Internet browsers. (Get more details about that case study by downloading this Pharma Marketing News article: "Medical Device Marketing: Worlds Apart from Rx Drug Marketing"; use discount code 'DEV444' BEFORE April 15, 2012 to get it FREE!).

While drug advertisers would sweat and moan over whether such a campaign would have a positive ROI (return on investment), medical device marketers don't need to worry about no stinkin' ROI because of such low numbers of conversions required AND also because very little resources need to go into premarket testing in order to get FDA approval.



Although the FDA has met most of its goals for fast-track medical device approvals, it's taking substantially longer to issue decisions on devices than it used to, concluded a report from the Government Accountability Office (GAO). The GAO said:

"FDA has begun to take steps to address GAO’s 2009 recommendation about high-risk devices that are allowed to enter the U.S. market through the less stringent 510(k) process, but progress has been limited. High-risk devices include those which are implantable or life sustaining. In 2009, GAO recommended that FDA expeditiously take steps to issue regulations for the device types classified as high risk that are currently allowed to enter the market via the 510(k) process. Since then, FDA has set strategic goals to address these device types, but has issued a final rule regarding the classification of only one device type. As of April 1, 2011, FDA’s action on the 26 remaining types of high-risk devices was incomplete. Thus, these types of devices—such as automated external defibrillators and implantable hip joints—can still enter the U.S. market through the less stringent 510(k) process. GAO found that, since its report was issued in January 2009, FDA has cleared at least 67 510(k) submissions that fall within these high-risk device types. FDA has taken some additional steps to enhance premarket device safety since GAO’s 2009 report was issued—for example, it commissioned the Institute of Medicine to conduct an independent review of the premarket review process—but it is too early to tell whether any forthcoming changes will enhance public health."

To get a copy of the GAO report, see the end of this post: "FDA Taking Longer to Approve Medical Devices, Says GAO"

Will Pharma Experience It's Own "Pink Slime" Social Media Crisis?

Will Pharma Experience It's Own "Pink Slime" Social Media Crisis?

No doubt you have heard about "pink slime," the beef additive made from leftover trimmings. According to an article in today's Wall Street Journal (here), "the additive, which has long been used as a cheap filler in hamburger meat without anyone knowing or caring, has become the latest example of a product to fall prey to a social-media feeding frenzy after celebrity chef Jamie Oliver detailed how it is made in a TV special. Facebook, Twitter and other social media sites took it from there. Supermarkets and school districts across the country have been shunning it after mounting public pressure."

To counteract that "public pressure," which Tyson Foods Chief Operating Officer Jim Lochner said is merely a "two-week event," USDA and governors from several "pink slime" producing states (eg, Rick Perry, Texas) are mounting a counterattack. Iowa Gov. Terry Branstad said "We're going to consume it. We'll do everything we can to set the record straight."

"This is so clearly a movement that's been driven by consumers," said Willy Ritch, a spokesman for U.S. Rep. Chellie Pingree (D., Maine), who is pushing for a ban of the filler in school lunches.

USDA chief Tom Vilsack pointed to the difficulty of getting ahead of opposition to a product -- even if it is deemed safe by the government -- in a world fueled by social media. He also highlighted a disconnect that continues to grow between people and where their food comes from.

It's possible that the drug industry will one day face it own "pink slime" crisis because there is also a "disconnect" between consumers and where their drugs come from and the ingredients they contain.

Recently, we have seen cases where active ingredients in medicines have been replaced by miscellaneous substances having no medical benefit and cases where manufacturing problems have led to contamination such as Johnson and Johnson's problems with children's medicines (see, for example, "Unsafe Drugs: Is It Counterfeiters or the Supply Chain That's the Problem?").

These problems may be glitches in an otherwise safe drug supply chain, but did you know that up to 80 percent of the active ingredients in drugs used in the United States are made overseas? Hopefully, those ingredients meet high standards. Yet up to 149 Americans died in 2007 and 2008 after taking heparin, a blood thinner, contaminated during the manufacturing process in China.

What's often not mentioned, however, are the "inactive" ingredients in the pills we take. Viagra, for example, contains the following inactive ingredients:

• microcrystalline cellulose
• anhydrous dibasic calcium phosphate
• croscarmellose sodium
• magnesium stearate
• hypromellose
• titanium dioxide
• lactose
• triacetin
• FD & C Blue #2 aluminum lake

Patients are warned to discontinue taking medicines if they are allergic to any of the ingredients.

These ingredients are the "pink slime" of the drug industry. But whereas "pink slime" only constitutes a small percentage of ground beef, these "inactive" ingredients comprise the bulk of the pill's weight and volume.  AND they are probably made overseas with very little FDA supervision.

One of these ingredients may be as controversial to patients as "pink slime" is to hamburger eaters. In fact, this was the case with Johnson and Johnson's baby shampoo that consumers learned contained cancer-causing chemicals. That issue was big on social media for a while until J&J promised to phase out the product in the U.S. (it has been completely pulled from the shelves in other countries).

The food industry is blaming "misinformation" amplified via social media as the main cause of the consumer backlash against "pink slime." They have launched a two-pronged campaign to deal with the crisis: (1) issue "corrective" information, and (2) warn of higher prices if "pink slime" is no longer used in hamburger meat.

This sounds similar to how drug companies view social media -- i.e., a vast network of "misinformation" about their products. The biggest argument social media advocates use to convince pharma to "engage" with consumers on social media is so that they can be "part of the conversation" and provide "scientifically correct" information about their products to counterbalance all the "misinformation" out there.

The first step is to learn what consumers are actually saying about drugs on social media. The drug industry is actively engaged in that kind of monitoring right now.

FDA Says No to Importation of Drugs That Save Lives, But Yes to Drugs That End Lives

FDA Says No to Importation of Drugs That Save Lives, But Yes to Drugs That End Lives

In the FAQs section of FDA's consumer web site (here), it answers the question: "Why can’t I import some drugs that are approved and sold in the United States?" thusly:

"Many drugs obtained from foreign sources that claim or appear to be the same as U.S.-approved drugs are, in fact, of unknown quality and may even be counterfeit. There is also a possibility that drugs coming to U.S.consumers through Canada, or that claim to be from Canada, may not actually be Canadian drugs. FDA cannot assure the authenticity, safety, or effectiveness of drugs from foreign countries."

However it does allow an exception at its discretion: "FDA, however, has a policy explaining that it typically does not object to personal imports of drugs that FDA has not approved under certain circumstances, including the following situation:

• The drug is for use for a serious condition for which effective treatment is not available in the United States;
• There is no commercialization or promotion of the drug to U.S. residents;
• The drug is considered not to represent an unreasonable risk;
• The individual importing the drug verifies in writing that it is for his or her own use, and provides contact information for the doctor providing treatment or shows the product is for the continuation of treatment begun in a foreign country; and
• Generally, not more than a 3-month supply of the drug is imported."

Certainly, that exception does NOT apply to sodium thiopental, an anesthetic used to put inmates to sleep before other lethal drugs are administered. Obviously, inmates are not importing this drug for "their own use."

However, the FDA has allowed prison officials in various states to import sodium thiopental after the drug’s U.S. manufacturer announced last year that it would no longer produce it.

As reported in the Washington Post (see here), U.S. District Judge Richard Leon blocked the importation of sodium thiopental on grounds the Food and Drug Administration "ignored the law in allowing it into this country." The Obama administration argued it had discretion to allow unapproved drugs into the U.S. Leon said the FDA’s actions were "contrary to law, arbitrary, capricious, and an abuse of discretion." He said that plain language of the law says that an article that appears to be misbranded or unapproved "shall be refused admission."

FDA cites safety concerns when it enforces the law of which Judge Leon speaks. A case in point, was the importation of tainted cancer drug Avastin (see "The Fake Avastin Supply Chain: China, Syria, Denmark, Switzerland, UK, US, Doctors").

Ironically, Judge Leon cited the same safety concerns:

"By opening up the 'closed' drug system by allowing an unapproved drug — thiopental — into the United States, defendants jeopardize their own system and threaten the public health by creating a risk that thiopental could incorrectly end up in the hands of the general public," he wrote.

AMEN!

The Fake Avastin Supply Chain: China, Syria, Denmark, Switzerland, UK, US, Doctors

The Fake Avastin Supply Chain: China, Syria, Denmark, Switzerland, UK, US, Doctors

Authorities investigating the importation of low-cost foreign pharmaceuticals into the U.S. have identified a supply chain that may have allowed fake cancer drugs to reach U.S. clinics, according to investigators and documents reviewed by The Wall Street Journal (see "Doctors, Drug Distributors Tied to Imports of Fake Avastin").

"In the case of the fake Avastin, its global route isn't yet clear, but what is known illustrates the circuitous path that pharmaceuticals can take before reaching consumers. Wherever the counterfeit Avastin was manufactured—possibly China—investigators are examining a zigzagging route that may have taken the product through Turkey and Egypt before it was sold to Swiss and Danish wholesalers and then to Mr. Haughton's U.K. wholesaler, River East Supplies Ltd., according to pharmaceutical-industry and law-enforcement officials. River East then shipped the product to U.S. doctors through a Tennessee distributor, according to Mr. Haughton."

It is illegal to import drugs that are approved by regulators in other countries, but not the FDA. It is also illegal for US citizens to knowingly or unknowingly purchase such drugs. This includes the doctors and clinics at the end of the chain who purchased the Avastin at below market prices ($1995 vs $2400 for a 400-milligram vial).

"Buying foreign-sourced drugs that don't meet FDA approval can carry criminal penalties for doctors who purchase them and then bill Medicare. Penalties can apply even to doctors who weren't aware the drugs were foreign."

It is even MORE illegal -- ie, immoral -- to purchase FAKE, counterfeit drugs such as the Avastin in question, which contained starch, salt, cleaning solvents and other chemicals and none of the drug's active ingredient, bevacizumab, according to Roche.

Here's my view of the Fake Avastin Supply Chain (sorry, but I couldn't fit all the complicit distributors in the image; eg, I left out Switzerland):

WHOOPS! I forgot the last element of the supply chain, the VICTIM, aka PATIENT!

How the Placebo Effect & Marketing Can Improve Health & Increase Pharma Profits

How the Placebo Effect & Marketing Can Improve Health & Increase Pharma Profits

Big pharmaceutical companies are drastically cutting back on research and development. The economics just do not support the model that has been the driving force of the drug industry over the past 15 years.

According to a Forbes analysis reported by Matthew Herper, "The average drug developed by a major pharmaceutical company costs at least $4 billion, and it can be as much as $11 billion" (see "The Truly Staggering Cost Of Inventing New Drugs").

Some pundits suggest that lowering the cost of performing clinical trials will help get more drugs to market faster. Andrew von Eschenbach, former FDA Commissioner and now employed as chairman of conservative think tank Manhattan Institute's Project FDA initiative, suggested that instead of the FDA asking pharma companies to complete "laborious clinical trials proving efficacy, after proof of concept and safety testing, the product could be approved for marketing with every eligible patient entered in a registry so the company and the FDA can establish efficacy through post-market studies" (see here).

However, Herper points out that the "main expense is failure. AstraZeneca (AZ) does badly by this measure because it has had so few new drugs hit the market." AZ spent about $59 billion on R&D between 1997 and 2011, but only managed to get 5 new drugs approved. According to simple arithmetic, that means each of these 5 drugs cost about $11.8 billion to develop.

That's an interesting number. A very similar number came up during last night's 60 Minutes segment on "Treating Depression: Is there a placebo effect?" (see it here). It turns out that antidepressants sales in the U.S. bring in $11.3 billion a year to pharmaceutical companies that sell them -- including AstraZeneca!

Could it be that the drug industry is merely "breaking even" in the anti-depressant market?

I suspect they are probably making a pretty good profit -- but that profit may be diminishing as more and more anti-depressants go off patent. In fact, it has been suggested that 60 Minutes dared to air this expose -- four years after the research was first published -- because the "news" can no longer harm the drug companies that CBS depends upon for advertising -- most of the drugs mentioned are off patent (see “You’re telling me this now?” Why the news is suddenly critical of statins and antidepressants).

I did a blog post about antidepressants and the placebo effect two years ago in January 2010 (read "A Common Goal of Research and Marketing: Fool the Doctor"). In that post, it was noted that clinical evidence suggests these drugs are not any more effective than a placebo in patients with less severe depression. But drug company marketing to physicians does not mention this. Thus, physicians are led to believe that the drugs ARE effective for all patients with depression.

As pointed out in the 60 Minutes piece, "a clinician who cares, who takes the time, who listens to you, who asks questions about your condition and pays attention to what you say, that's the kind of care that can help facilitate a placebo effect." That goes double if the clinician actually believes what he or she is prescribing is a drug with proven efficacy.

Consequently, marketing to physicians along with direct marketing to consumers can play a huge role in "facilitating" a placebo effect. Which leads me to this idea: pharmaceutical companies should be in the business of developing placebos rather than dangerous, ineffective chemical compounds. There would be no need for expensive clinical trials and it would be easy for FDA to adopt von Eschenbach's idea to approve these new "drugs" before they are proven effective. It will be up to marketing to make them effective by facilitating the placebo effect!

Of course, to be successful, this new approach to drug development must be done surreptitiously and the FDA must conspire with the drug industry (not too much of a stretch there). After all, if everyone knows that the drug industry is manufacturing placebos, the game is up -- doctors will know that they are prescribing placebos and so would patients. That knowledge will render the placebo ineffective. This is a case where a knowledgeable patient is at a disadvantage.

It should be noted, however, that many physicians in some countries knowingly prescribe placebos. Results of a survey published in the British Medical Journal (BMJ) indicate that "about half of the surveyed internists and rheumatologists reported prescribing placebo treatments on a regular basis. Furthermore," say the researchers, "physicians who use placebo treatments most commonly describe them to patients as a potentially beneficial medicine or treatment not typically used for their condition; only rarely do they explicitly describe them as placebos" (read this).

J&J Recalls Grape-flavored Children's Tylenol: Another Missed Opportunity for Social Media

J&J Recalls Grape-flavored Children's Tylenol: Another Missed Opportunity for Social Media

[Great minds think alike! Be sure to read Update at end of this post.]

Here's another case where CHEAP social media -- ie, YouTube -- could have been used by a pharmaceutical company to support patients using its products, but was not.

Johnson & Johnson DID use social media -- Twitter -- to inform followers of its decision to recall of U.S., Infants’ TYLENOL® Oral Suspension, 1 oz. Grape. According to a letter sent to J&J employees' Denice Torres, who’s the President of McNeil Consumer Healthcare, a subsidiary of Johnson & Johnson, said:

"We’re recalling the product at the retail level after receiving a small number of complaints from consumers who reported difficulty using the product’s SimpleMeasure™ dosing system. SimpleMeasure™ includes a dosing syringe, which a parent or caregiver inserts into a protective cover, or “flow restrictor,” at the top of the bottle to measure the proper dose. In some cases, the flow restrictor was pushed into the bottle when inserting the dosing syringe. No adverse events associated with this issue have been reported to date and the risk of a serious adverse medical event is remote."

The letter was posted on the JNJBTW Blog (see here), to which the Twitter post mentioned above linked. J&J will offer people a refund, which is good. But are they abandoning the new dosing system, which is also a good idea? Perhaps it needs a new design, but even so, it should include instructions for use -- and not just written instructions, which many people won't understand. Video would be better.

So, I immediately thought: "Why didn't J&J post a video on YouTube that showed people how to use the dosing syringe?"

Such a video would be almost as easy and cheap for J&J to create as the post to JNJBTW. And it would be more likely to be seen by consumers because YouTube is the second -- maybe now the first -- most used search engine on the Internet! The video could also be embedded within the product web site. [Or even at the end of blog posts such as this one!]

I did a quick search of the product web site and found no information on how to use the SimpleMeasure™ dosing system and no video.

Last week I attended the ePharma Summit, which included a popular presentation titled "I wish I'd Done That! Social Media." Presenters would review competitors' social media campaigns that they liked.

What we really need is a session on "The Social Media We Should Have Done, But Didn't!." I think I will gather my contenders for this session and post them here!

Meanwhile, I hope this gives J&J an idea.

UpDate:
I just learned learned via a Twitter post from @JNJComm at 10:05 AM that there is a YouTube video on How To Use Infants' TYLENOL® SimpleMeasure™: Watch a video about how to use Infants’ TYLENOL Simple Measure > http://www.youtube.com/tylenol

Former FDA Führer von Eschenbach Favors Approving Drugs for General Use Without Proof of Efficacy!

Former FDA Führer von Eschenbach Favors Approving Drugs for General Use Without Proof of Efficacy!

Andrew von Eschenbach, famous for resigning as FDA commissioner and leaving the agency leaderless on the very day that Obama was inaugurated (see Eschenbach Announces Resignation, FDA Staffer Throws Shoes in "Farewell Kiss"), is now employed as chairman of conservative think tank Manhattan Institute's Project FDA initiative.

If von Eschenbach has his way, FDA will be out of the business of approving new drugs based on efficacy, but will merely rubberstamp any drug that won't kill humans outright! In essence, the entire U.S. population will become non-volunteer experimental subjects. A drug's efficacy will be proven (or not) in the marketplace.

Instead of the FDA asking pharma companies to complete "laborious clinical trials proving efficacy," says von Eschenbach in a WSJ Op-Ed piece (see here), "after proof of concept and safety testing, the product could be approved for marketing with every eligible patient entered in a registry so the company and the FDA can establish efficacy through post-market studies."

This is free market economics gone wild!

Currently, "post-market studies" are a undertaken to test the SAFETY of drugs as they are used in the real world. Such studies are not required of all drugs. What von Eschenbach proposes is to use post-market studies to test if drugs work as advertised, not if they are safe.

The problem is that post-market studies are NOT scientific because there are no controls to determine a baseline against which to measure efficacy. It's easy to find safety problems because that does not require controls.

I am amazed that von Eschenbach headed up the FDA and before that the National Cancer Institute! The fact that he is advocating tossing the scientific method aside takes my breath away considering that he is now well-positioned in the conservative political arena and no doubt has hopes that a future Romney or Gingrich administration will appoint him FDA commissioner or worse, Secretary of the Department of Health and Human Services!

Pfizer's Contraceptive Recall: A Statistical Needle in a Haystack!

Pfizer's Contraceptive Recall: A Statistical Needle in a Haystack!

All day yesterday, the news swirled through social media about Pfizer's voluntary nationwide recall of contraceptive tablets due to the possibility of "inexact tablet counts or out of sequence tablets." As a result of this packaging error, the daily regimen for these oral contraceptives may be incorrect and could leave women without adequate contraception, and at risk for unintended pregnancy. That's a serious issue for any woman affected and it obviously warrants a recall.

Although Pfizer issued a timely press release dated 31 January 2012 -- which was picked up by the news media -- it did not post a tweet notice via @pfizer_news until about 5 PM yesterday. That tweet announced "Chief Medical Officer Freda Lewis-Hall Addresses Company's Voluntary Recall of Contraceptive Products" and linked to a YouTube video (embedded in this post below). A good use of YouTube -- although the video has only been viewed 444 times so far. But waiting for the video to be produced before sending out a notice of the recall via Twitter was not a good idea considering that nearly 24,000 people follow @pfizer_news!

I'm just curious why Pfizer didn't send out a tweet as soon as it published its press release on 31 January? In one step, 24,000 people could have been directed to the press release. Anyway, here's the video:



Did you hear Dr. Freda Lewis-Hall tell us how many packages Pfizer thinks were faulty? "We believe there are approximately thirty packs of birth control pills that may have received an inexact count or inactive tablets," she said. THIRTY! To retrieve these 30 packages, Pfizer recall 14 lots or approximately 1 million packages! I'm not a mathematician, but the odds that any of these 30 packages will be in the actual packages recalled must be very slim. After all, you can say you are recalling 1 million packages, but how many will actually end up back in Pfizer's warehouses? I imagine a voluntary recall is very INEFFICIENT.

30 out of 1,000,000 is 0.0003%. Even if a voluntary recall sweeps in 99.99% of the 1 million packages, that leaves 0.01% still out there. That's 33 times the number of faulty packs.

Mining FDA's AER Database: Heaven for Hypochondriacs, Hell for Pharma

Mining FDA's AER Database: Heaven for Hypochondriacs, Hell for Pharma

A story in yesterday's WSJ Health featured AdverseEvents Inc., a start-up company that has streamlined the FDA's "often impenetrable" adverse drug event database and made it easy to search the adverse-event reports (AERs) for more than 4,500 drugs, free and online (see here).

I interviewed Brian M. Overstreet, founder and president of Adverse Events, last September on my Pharma Marketing Talk show. You can use the widget below to listen to that interview>



The pharmaceutical industry is a bit nervous about consumers getting easy access to FDA's "hidden" treasure trove of AERs:

Kate Connors, a spokeswoman for the Pharmaceutical Research & Manufacturers of America, which represents most drug makers, said the group isn't familiar with AdverseEvents and believes the FDA is the most appropriate source of information. "We think it's important for this information to be framed within context and to be properly evaluated," she says.

But the FDA passes the buck as far as being the authoritative source for AE info. As reported in the WSJ, FDA's site warns that its AER files "cannot be used to calculate the incidence of an adverse-event in the U.S. population." For consumers who want more information on drug side effects, "the best source is to read the product label and talk to your doctor or pharmacist," says Gerald Dal Pan, director of surveillance and epidemiology in the FDA's Center for Drug Evaluation and Research.

"Read the product label"! That's a joke, right? FDA hasn't made much progress simplifying drug labels either because of industry resistance or being forced to do endless studies on the issue (see, for example, "FDA Plans to Test New Standard for Easy to Understand Rx Labels").

Meanwhile, how risky are Rx drugs? I invite you to take "Harry's Drug Risk Parlor Game" and rate the overall risk of Rx drugs (you will be able to see the results to date afterward).

[Hat Tip to @Pernajl for the "heaven for Hypochondriacs" part of this blog post title.]

FDA's Advisory Committee Voting Double Standard

FDA's Advisory Committee Voting Double Standard

I learned today that the FDA allowed physicians with ties to Bayer to participate and vote in an advisory committee weighing whether or not the benefits of four popular Bayer AG birth-control pills outweigh the blood-clot risk (read the WSJ story here: "FDA Advisory Committee Members Had Ties to Bayer").

At least one of the physicians (Paula Hillard, Stanford Univ; see her financial disclosure info here) was a Yasmin advocate. According to a Bayer document released during litigation, Hillard "enable[d] us [Bayer] to now have another huge ... Yasmin advocate here in Nor Cal -- she will be well utilized!"

Hillard, the advocate, was allowed to vote on the issue.

In the same story, it was noted that drug-safety crusader Sidney Wolfe -- who was appointed to a four-year term on the FDA's Drug Safety and Risk Management Committee (see "Wolf(e) at DTC Piggy's Door Huffing and Puffing") -- was NOT allowed to vote "because he had publicly criticized the drugs' safety in newsletters published by his Public Citizen Health Research Group."

So, an "advocate" of a drug is allowed to vote whereas a "critic" of a drug is not allowed to vote. This is an astonishing double standard, IMHO.

This little excerpt from the WSJ article is also interesting:

The FDA says members of the public speaking before advisory committees must declare any financial relationships to the relevant drug maker, to "ensure ... transparency." However, committee members must disclose potential conflicts only to the FDA, which doesn't generally make the information public.

Jill Hartzler Warner, an FDA official who oversees advisory committees, said the agency is "prohibited from giving the public any information contained in a financial disclosure" from committee members. When picking committees, the FDA weighs "whether a meeting would affect the financial interest" of a panelist. The agency also does "look at whether past relationships would give the appearance of being a conflict," she said.

I was not aware that the FDA is "prohibited" from supplying information contained in financial disclosures, but it may be a moot point in a year or so when the physician sunshine act is in full effect and all payments to physicians are made public. We'll just have to wait for that and do our own research. Still, with FDA's double standard regarding voting privileges, it won't much matter how much transparency there is in who serves on these committees!

P.S. For more on how the FDA determines whether or not a physician's financial conflicts disqualifies him or her from serving on FDA advisory committees, see "FDA Advisor Rule Loophole?" where you'll find a complex chart depicting FDA's "Algorithm for Considering Advisory Committee Member Participation."

P.P. S. For some more background on Wolfe vs FDA regarding Wolfe's participation in this committee, read "FDA Pulls Wolfe Off Panel Over ‘Intellectual’ Conflict" (Pharmalot).

Predicting the Future of the Drug Industry: 2012 and Beyond

Predicting the Future of the Drug Industry: 2012 and Beyond

It's time to revisit a survey I ran a couple of years ago that attempted to predict future healthcare market scenarios that would impact the drug industry. The survey asks respondents how likely it is for certain events or conditions to unfold in the next 5 to 8 years (ie, 2012 to 2019).




You can take the survey here. But before you do that, let's review the first-round of results (ie, responses collected from 2 December 2009 through 8 January 2010). Events since then may have made some of the following scenarios more or less likely. You tell me.

The scenarios -- with my updated comments included in brackets [] -- that are included in the survey are as follows (see the chart afterward for the first-round results):

1. New follow-on biologics legislation in the U.S. will increase competition from generic equivalents and eventually decrease brand profits. [I think the legislation is still bogged down and when finalized may not have much impact within the time frame specified.]
2. Broadcast (ie, TV) Direct-to-Consumer (DTC) drug promotion will be banned or sharply curtailed by law in the U.S. [This may have been a big issue back in the day, but it doesn't seem to be center stage right now.]
3. The European Union will finally allow Direct-to-Consumer (DTC) advertising to its citizens. [The European Commission, the executive arm of the EU, recently ruled that pharma companies would not be allowed to disseminate information about drugs and their indications beyond a narrow set of circumstances. For the details, see, "In Rejecting Proposal, EU Dashes Drugmakers’ Hopes of Having a Voice"]
4. Internet-based drug promotion (including search engine marketing) will overtake TV-based DTC in the U.S. in terms of dollars spent. [There's still time for this to happen. I'm guessing that right now only about 5% (maybe 10% if you include search advertising) of pharma's DTC advertising budget is spent on Internet advertising whereas TV accounts for over 50% of the budget. See "Double Dip in DTC Spending Plus 33% Drop in Internet Display Ad Spending!"]
5. Due to decreasing effectiveness of traditional physician detailing and rise of non-personal detailing, the role of traditional sales representative will become obsolete. [I'm surprised that over 50% of respondents think this is likely to happen before 2020 (see chart below). Perhaps a sign is the recent closing of Pharmaceutical Representative Magazine (see here). Also read this article: "Consequences of eDetailing Technology".]
6. New healthcare reform legislation will dramatically increase the sales of drugs in the U.S.
7. Extensive outcomes data available to payers and comparative effectiveness research will force the industry much further down the path of pay-for-performance (ie, adopt a more flexible approach to pricing). [For background in this, read the article "A Case for Supporting Comparative Effectiveness Research".]
8. Patients will become even more influential and empowered in making healthcare decisions as they are forced to pay a larger share of costs and/or have access to health information from a variety of sources. [For more background on this, read the article "The Empowered Patient: What It Means for Pharma Marketers".]
9. Despite lack of innovative new drugs and/or generic competition, sales of brand drugs worldwide will show a sharp increase due to increased demand in emerging markets (eg, China). [See the following articles: "Getting Market Research Right in Emerging Markets", "Getting Market Research Right in the Middle East", and "Getting Market Research Right in India & China".]
10. More efficient targeting of drugs and marketing to specific patient populations will greatly increase effectiveness and decrease side effects of drugs. [See, for example, "New Big Pharma Economies of Scale: Less Patients Needed to Reach Blockbuster Sales". At least one targeted therapy (I can't recall which), however, recently failed and that may cast a shadow on progress in this area.]
11. Social media marketing will become a significant part (>10%) of the pharmaceutical marketing mix. [Hmmm... A lot of people seem to believe this is likely (see chart), but FDA's delay in issuing guidance may have dampened the outlook for pharma use of social media.]
12. The next BIG opportunity for targeted marketing to patients and physicians is mobile apps on "smart phones." [To prepare for this, I recommend you read the article "Everything You Need to Know About Mobile Platforms". Take the survey and you will get a discount code that allows you to get this at no charge.]
13. Pharmaceutical and biotech companies will continue to increase their outsourcing of clinical trials and related drug development. Outsourcing will account for more than 50% of R&D spending by 2019.

The following chart summarizes first-round (prior to January 2010) survey results. Please take the survey now and help me get a more current view of what may be dow the road.