Recently in Drug industry Category

Can local TV news do more than scratch the surface on important health news? My former student Jeff Baillon (There - the disclosure is out of the way) shows once again how well it can be done. He reported this week on the widely-prescribed proton pump inhibitor drugs for heartburn. But his angle was not one of breathless awe. Rather, he reported that "there's scientific evidence that these medicines might also cause the problem they're designed to cure."

What will Pharma do to maximize profits? The answer isn't theoretical. It's happening right now.

Duff Wilson of the NYT reports:

Even as drug makers promise to support Washington's health care overhaul by shaving $8 billion a year off the nation's drug costs after the legislation takes effect, the industry has been raising its prices at the fastest rate in years.

In the last year, the industry has raised the wholesale prices of brand-name prescription drugs by about 9 percent, according to industry analysts. That will add more than $10 billion to the nation's drug bill, which is on track to exceed $300 billion this year. By at least one analysis, it is the highest annual rate of inflation for drug prices since 1992.

The story includes input from Prof. Steve Schondelmeyer of the University of Minnesota, who, for 6 straight years, has given of his time to come and speak to my undergrad and graduate health journalism students on pharma and pharma pricing issues.

Consumer Reports' terrific series of drug adwatch videos added a new one last week - and this is one of my favorites.

An article in PLoS Medicine by David Henry, Lisa Bero, Ray Moynihan and colleagues analyzes Australia's move to require disclosure of medical industry funding of any event. Their summary points:

* There are moves internationally to ensure greater disclosure of gifts and educational events for doctors paid for by pharmaceutical manufacturers. However, there is no agreement on appropriate standards of disclosure. In Australia, since mid-2007, there has been mandatory reporting of details of every industry-sponsored event, including the costs of any hospitality provided.

* Examination of the Australian data shows that although expenditure at individual events is often modest, cumulative expenditure is high, particularly in the case of medical specialists prescribing high cost drugs--oncologists, endocrinologists, and cardiologists.

* Although a significant advance, the new Australian reporting standards do not allow assessment of the educational value of sponsored events, and do not include details of speakers or educational content for most events. However, doctors in training are often present at these events.

* At present, the standards of disclosure are inadequate and should not be tied to an arbitrary monetary value of gifts or sponsorship. Reporting standards should require the names of the speakers presenting, whether sponsors played a role in suggestion or selection of speakers or the development of the content of presentations, and the nature of any direct or indirect financial ties between the speakers and the sponsors.

Blogger Merrill Goozner writes:

There was bad news for cancer patients -- and the biotechnology giant Amgen -- buried in a clinical trial released early yesterday by the New England Journal of Medicine.

The Amgen-funded trial was designed to show that people with failing kidneys given Aranesp for mild anemia had fewer deaths and major cardiovascular events than people given nothing. The company had hopes of expanding use of the drug among chronic kidney disease (CKD) sufferers.

But those hopes were dashed by the results of the 4,038-person trial. Not only was there no cardiovascular benefit for the 2,012 people given a regular shot of the drug, people on Aranesp suffered twice as many strokes.

But the results were even worse for people with CKD who either had a previous history of cancer or were diagnosed with the disease during the trial (188 in the Aranesp arm and 160 in the placebo arm). Those taking Aranesp had a statistically significant increase in cancer mortality.

Overall, 39 died from cancer when taking Aranesp compared to just 25 who died from cancer in the placebo arm. But all of that increase was among people who had cancer or had a cancer history when they entered the trial. Among that group, 14 died while on Aranesp while only one died while on placebo.

The bottom line is that Aranesp, and perhaps by extension Procrit/Epogen, which are short-acting versions of the same recombinant protein, probably is "Miracle-Gro for Cancer," to use American Cancer Society president Otis Brawley's now famous phrase.

These results, which came from the kind of randomized study considered the gold standard of research and which counter years of aggressive marketing by Amgen, were released hours after the attorneys general from Massachusetts and 14 other states sued Amgen in federal court alleging that the company offered kickbacks to doctors to boost sales of Aranesp.

Steve Woloshin and Lisa Schwartz of the Dartmouth Institute for Health Policy and Clinical Practice publish an important perpective piece, "Lost in Transmission -- FDA Drug Information That Never Reaches Clinicians," in this week's New England Journal of Medicine.

It's about how "critical information that the FDA has at the time of drug approval may fail to make its way into the drug label and relevant journal articles."

Examples they write about: sleeping pills Lunesta and Rozerem. Excerpts:

"Clinicians who are interested in (Lunesta's) efficacy cannot find efficacy information in the label: it states only that Lunesta is superior to placebo. The FDA's medical review provides efficacy data, albeit not until page 306 of the 403-page document. In the longest, largest phase 3 trial, patients in the Lunesta group reported falling asleep an average of 15 minutes faster and sleeping an average of 37 minutes longer than those in the placebo group. However, on average, Lunesta patients still met criteria for insomnia and reported no clinically meaningful improvement in next-day alertness or functioning.

A sense of uncertainty about the net benefit of drugs is almost always lost. FDA approval does not mean that a drug works well; it means only that the agency deemed its benefits to outweigh its harms. ...

Rozerem (ramelteon), for example, was approved in 2005 for chronic insomnia and was aggressively promoted to consumers. No efficacy data were provided in the label....The Rozerem review included a memo from the medical review team's leader, highlighting the team's struggle to determine whether this drug provided any clinically important benefit and whether that benefit outweighed the harms. ... The sense that the FDA's decision was a close call was not communicated in the label."

The authors have urged the FDA to consider a "drug fact box" featuring a data table of benefits and harms to be used in reviews, labels or both.

They conclude:

"We don't need to wait for new comparative-effectiveness results in order to improve practice. We need to better disseminate what is already known."

John Mack wrote a noteworthy Google Sidewiki:

"Yesterday (8-OCT-2009 and the day before), while watching the Phillies-Rockies playoff baseball game on cable TV (TBS), I saw a Viagra ad at 5:23 PM.

I believe that this violates PhRMA's DTC principle #16, which states: "In terms of content and placement, DTC television and print advertisements should be targeted to avoid audiences that are not age appropriate for the messages involved. In particular, DTC television and print advertisements containing content that may be inappropriate for children should be placed in programs or publications that are reasonably expected to draw an audience of approximately 90 percent adults (18 years or older)."

I doubt that a 5:23 PM on a weekday afternoon, 90% of the audience for this show was 18 years or older. I challenge Pfizer to offer proof otherwise.

Perhaps Pfizer accepts the word of TBS that the audience is appropriate at that time, but what's need is actual Neilson data or the equivalent. If TBS is using historical viewer data for that time slot that is not sports related, then I think it is faulty proof.

A TV network is likely to spin viewer data to woo advertisers, but advertisers should not just take their word for it."

....is promoting drugs for drugmakers.

Read Dan Carlat's latest on how Lilly is pushing its fibromyalgia drug through CVS Caremark.

Liz Kowalczyk of the Boston Globe reports:

At least 60 Massachusetts doctors collectively have earned more than a half-million dollars this year as speakers paid by pharmaceutical giant Eli Lilly & Co. - including two Boston Medical Center physicians whose participation is being reviewed for possible violation of a hospital policy against marketing activities by its doctors. ...

Hospital spokeswoman Gina Digravio initially told the Globe last week that the two doctors did not violate the hospital's policy, because they said they "fully determined their presentations.'' The two-year-old rule bars doctors from giving industry-sponsored talks unless the "lecture's content, including slides and written materials, are determined by the clinician.'' Lilly, however, says on its website that it alone provides the information presented by speakers. Spokeswoman Carole Puls said the company provides slides and other materials.

Later in the week, the hospital revised its position, saying, "we have instructed the doctors to refrain from any further presentations pending a review by the medical campus provost.''

As Merrill Goozner points out on his blog, this is:

"a story we should see in abundance if Congress passes the Physician Payments Sunshine Act, which is in the House and Senate versions of health care reform legislation. ...

The story was made possible by the fact that Lilly is one of the first companies to voluntarily list physician payments on its website. Enterprising reporters in other parts of the country should take note, especially as more companies move to put their disclosures online."

The American College of Physicians released a new policy paper (pdf file) this week that criticizes the FDA's ability to approve and monitor new drugs, and makes recommendations for improvement.

One was to stiffen requirements for drugmakers to report adverse events after drugs are approved and on the market. Excerpt:

Despite (the current) requirements, it has been estimated that only 1% of all adverse drug events and 10% of serious adverse drug events are reported. Critics of the current system have pointed to the inherent conflict of interest in asking the industry to monitor its own drugs, an issue which is magnified by the intense direct-to-consumer advertising and promotional efforts directed toward physicians, especially during the initial and product launch phases.

And then, on the issue of direct-to-consumer drug ads, the paper recommends:

Grant the FDA the authority to require that newly approved drugs have a special symbol on their labels to help increase public awareness that they are new, and limit direct-to-consumer (DTC) advertising for the first 2 years after approval.

"The Misperception That Clinical Trial Data Reflect Long-term Drug Safety" is the title of a commentary in this week's Archives of Dermatology.

The authors focused on one particular drug - Raptiva (efalizumab) for psoriasis - and the fact that the European Medicines Agency (EMEA) has recommended the suspension of the marketing authorization for it after concluding that its benefits no longer outweigh its risks. But their conclusion carries a much broader message than just about this one drug:

There is the misperception by the public and many physicians that drugs are "safe and effective" as is often concluded in (approval) randomized clinical trials (RCTs). This phrase suggests, without equivocation or nuance, that drugs work and do not have (serious) adverse effects. The real meaning of this phrase is that a particular drug--for the approved indication, in the approved patient population, and at the approved dosing schedule and administration--has an efficacy profile that warrants being marketed despite its known toxic effects. Or more concisely, at time of approval, the known benefits outweigh the known safety risks. To fully appreciate the benefits of a drug, it should be compared with existing standard therapies and not merely show superior benefit compared with placebo. How a new drug will act and how patients in more complex real-life settings than in those eligible for RCTs (eg, healthy patients) will react is not known and needs to be robustly monitored in postmarketing safety studies that include a large heterogeneous patient population for at least 5 years and are performed swiftly after drug approval so that they may have an impact on clinical care.

Yet, as we've seen, the track record for swift postmarketing safety studies is not good.

Psychiatrist Daniel Carlat has been blogging this week about drugmaker Schering-Plough making "aggressive use of hired guns to get psychiatrists to prescribe its new antipsychotic" SAPHRIS (asenapine) for the treatment of both schizophrenia and bipolar disorder.

Carlat writes:

"Oddly, the company just sent me a SAPHRIS Speaker Bureau invitation packet. I guess my 2007 New York Times Magazine memoir describing the tangled ethics of promotional speaking has not yet become required reading at Schering-Plough. ...

They offered me $170,000 for 125 presentations (of 45 minutes each)...

What a fiasco for the company. Talk about a bad stumble as they are about to launch their new antipsychotic. I haven't heard any official Schering-Plough comment on this matter yet, but here is how I predict the statement will read: "Speaker programs are intended to enhance a healthcare professional's knowledge and patient care expertise." Wait--they can't use that line, because it was already used by Eli Lilly. I guess they'll have to make up their own sophisticated BS."

On the Pharma Marketing Blog, John Mack writes about weight loss drug Alli:

"Alli is a great case study of what pharmaceutical companies would do if there were fewer or no FDA regulations to contend with - they would enhance the benefits and downplay the side effects."

1. Pfizer gets hit with a record $2.3. fine for off-label marketing of drugs.

2. Forest Laboratories' marketing shenanigans for its antidepressant Lexapro. As the New York Times reported:

"A document quietly made public recently by the Senate's Special Committee on Aging demonstrates just how Forest managed to turn a medicinal afterthought into a best seller. ... (the document makes) clear that one of the principal means by which Forest hoped to persuade psychiatrists, primary care doctors and other medical specialists to prescribe Lexapro was by finding many ways to put money into doctors' pockets and food into their mouths."

3. Schering -Plough motion to dismiss is denied - as reported by ShearlingsPlowed.com:

(The judge has) gone out of his way to signal that he thinks the plaintiffs have mustered-up a pretty good set of claims:

. . . .Plaintiffs, purchasers of Schering-Plough Corp. ("Schering") securities during the period July 24, 2006 to March 28, 2008, allege that Schering, five members of its senior management, eleven of its current directors and one former director, and eighteen underwriters that participated in Schering's August 2007 public stock offering (the "Offering") are liable in damages for unlawful misstatements and omissions made in connection with the Offering relating to the cholesterol drug Vytorin and the ENHANCE clinical study. . . .

4. Merck price-gouging its HIV drug? ShearlingsPlowed.com reports this one, too:

AIDS Healthcare Foundation (AHF) today unveiled its latest advocacy campaign challenging Merck and Co. Pharmaceuticals over the steep price of its key HIV/AIDS drug, Isentress (raltegravir). The first phase of the public awareness campaign includes a postcard mailer, scheduled to arrive this week in the mailboxes of residents of Whitehouse Station, New Jersey, where Merck is headquartered. The front of the postcard features a mock "Wanted" poster with an artist rendering of Merck CEO Richard T. Clark pictured beneath the headline: "WANTED: Criminal AIDS Drug Pricing."

5. Merck in court over Fosamax problems, as reported by the NY Times:

Drug executives, product liability lawyers and Wall Street analysts are closely watching a jury trial in New York over medical problems associated with Fosamax, a drug from Merck that has been taken by millions of women to offset the bone loss associated with menopause.

It is the first of about 900 state and federal cases pending against Merck in which plaintiffs claim that taking Fosamax caused them to develop a rare problem called osteonecrosis of the jaw.

For people who cover the drug industry or follow the drug industry closely, this is probably not an extraordinary week.

Which is an extraordinary observation in itself.

What's that about market solutions to health care reform?