When I began writing this blog, back in August of 2007, I published a story about Provenge, a controversial drug that was causing quite a stir both on Wall Street and in the medical community. Now Provenge is back in the news, and the New York Times is taking a beating for supporting the drug before the evidence is in.
First, here’s the background to the story. My original post began:
“Only in America do physicians who evaluate new drugs need bodyguards. You may have read about the brouhaha surrounding Provenge, a vaccine designed to extend the lives of men suffering from late-stage prostate cancer. In March, a Food and Drug Administration (FDA) advisory panel voted 13 to 4 to recommend approval.
“The next day, shares of Dendreon, the drug’s sponsor, doubled. But shareholders did not celebrate for long. Two of the dissenting votes were cast by the panel’s two prostate cancer specialists: Sloan-Kettering’s Howard Scher and the University of Michigan ’s Maha Hussain. And they did not just vote “no”—following the hearing, both wrote to the FDA arguing that Dendreon offered no solid evidence that Provenge works.
“The FDA listened. And in May it told the company it wouldn’t approve the drug until it had more data. That is when the two oncologists began receiving threatening e-mails, phone calls, and letters. Many were anonymous
“No doubt much of the hate mail came from investors who had watched Dendreon’s shares climb from $5 in early January to $25.25 in late March—before plunging to $3 and change. One Alabama shareholder expressed his feelings on his MySpace page, where he asks “Hey, Hey, FDA, How Many Dads Did You Kill Today?” while images of Hussain and Scher flash across a backdrop of crooked crosses. Mozart’s “Requiem” plays in the background.
“The response illustrates how, in a money-driven health care system, those who view health care as a profit center strive to dictate social policy. From their point of view, the FDA should approve any product that Wall Street finds attractive—and then let the market decide whether or not the drug is both safe and effective. What they ignore is that, unlike other consumers, sick patients are not in a good position to comparison-shop. They must rely on the doctors and scientists who serve on FDA panels to sort through the hundreds of offerings that drug makers hope to bring to market. For even if a drug makes it to Phase III trials, this is no assurance that it is safe—or that it will work. Indeed, a recent study shows that fully 40 percent of new drugs fail in that final stage of testing.
“So far, the FDA has not bowed to investor pressure regarding Provenge, but the e-mails and phone calls were too menacing to be ignored. When Hussain and Scher attended the conference of the American Society of Clinical Oncology last month, both asked for extra security guards. At that point, Hussain began wondering whether she should continue as an FDA adviser.
“Patients also protested the FDA’s decision. Many had pinned their hopes on Provenge because it is one of a group of new cancer drugs under development that uses the patient’s own cells to create a vaccine designed to mobilize the patient’s immune system to attack the cancer. The notion that the body might “heal itself” is enormously seductive. For more than a century, oncologists have dreamed of such a solution. But thus far, as Dr. Steven A. Rosenberg of the National Cancer Institute confirmed in an e-mail to me last week, ‘there are no therapeutic vaccines that have been shown to be effective.’
“This is not what patients want to hear. But while many were crushed by the FDA’s decision, patient advocates such as
PSA Rising disown the hate mail. ‘Folks, this is not grassroots cancer patient activity, it’s . . . naked grassroots investor activity,’ wrote Jaqueline Strax, the editor of PSA Rising, in her newsletter for prostate cancer survivors. Ironically, some investors have whined that prostate cancer patients are not helping THEM on behalf of Dendreon.”
“Meanwhile, shareholders charged that Sloane-Kettering’s Scher nixed the drug because he is the lead investigator for a rival product. To drive this point home, earlier this month Provenge activists raised $24,000 on the Dendreon message board at Investor Village to buy a half-page ad in the Washington Post headlined ‘Prostate Cancer Victims Face Needless Suffering and Premature Death.’
“Could this be true? Knowing how much misinformation swirls around any new cancer drug, I decided to take a close look at the transcript of the FDA hearing and find out more about the scientific evidence behind Provenge.
“This is when my skepticism turned to shock. First, I learned that Dendreon has done two clinical trials attempting to show that Provenge slows the progress of the cancer. And that both failed. That’s right—the studies offered absolutely no proof that the drug put a brake on the disease.
“’It’s not clear why the FDA panel was even voting on the drug—Provenge had already been check-mated,” says Paul Goldberg, who broke the story by printing Scher’s letter to the FDA in The Cancer Letter, a weekly newsletter about the politics of cancer.
“But Dendreon persisted. Undeterred by the failed trials, the company went back and found another way to slice and dice the numbers. It turns out that in a small trial of 172 men, the group who received Provenge lived an average of 4½ months longer than those who received the placebo. There was, however, no scientific evidence that they lived longer because they received Provenge.
“As Mario Sznol, a medical oncologist at Yale points out, “A lot of these trials of cancer [drugs like Provenge] are small, and their response rates are low. That means some positive findings could simply be due to chance.”
“At the hearing Hussain also pointed out that there was no data showing that Provenge slowed the development of pain. Asked about quality of life during those extra 4½ months, the company replied: “We didn’t study that.”
“Of course they didn’t. When late-stage prostate cancer spreads, patients can experience severe bone pain.”
Now, Provenge is back. Last week, the New York Times published a story under the banner: “Promising Test for Dendreon’s Prostate Cancer Drug.” Note that the company’s name is in the headline. The story originally was published in the Times business section: it’s a story for investors (alerting them that they might want to buy the stock) not a story for doctors or patients concerned about prostate cancer.
The Times noted that the FDA had refused to approve Provenge two years ago, quoting “Ted Girgus of
Bellingham, Wash., who has advanced prostate cancer.”
”’Since that delay, we have lost a lot of good men,’ Girgus told the Times, calling the F.D.A. decision ‘a punch in the stomach.’” In the next sentence, without skipping a beat, the Times notes that Girgus, “also owns Dendreon stock” and quotes him saying that “patients like himself were ‘looking into the abyss.’”
For a moment it wasn’t entirely clear whether the abyss was an unknown afterlife, or the possibility that the stock will never come back. (After years of covering Wall Street, I can only tell you that some investors take their favorite stocks very, very seriously. I, too, have read hate mail. It’s scary because the people who write it are unquestionably unhinged.)
As for the promising new test, the Times had little information: “Dendreon did not reveal the actual results of its trial, saying they would be presented at a urology meeting on April 28. That left some analysts uncertain how well the drug really worked.
“But Mitchell H. Gold, the company’s chief executive, told analys
ts in a conference call that the outcome was "unambiguous" and met the goals the company and the F.D.A. had agreed upon and that the results were consistent with those seen in earlier trials of Provenge.
“In an interview, Dr. Gold said Provenge would have had to reduce the risk of death by 22 percent compared with a placebo to meet the F.D.A. requirements for statistical significance.
“Dendreon’s stock soared on the news. The shares were up more than 130 percent for the day, closing at $16.99.”
The only hard information the Times has is that the stock levitated. That seems the raison d’etre for the piece: good news for investors, at least for the moment. When the actual results of the trial are presented on April 28, they could be in for a major disappointment.
In the Cancer Letter, Paul Goldberg reports that skeptics are waiting for the data. As Merrill Goozner reports on GoozNews, “Goldberg quoted experts expressing concerns about the vaccine's side effects (including a higher number of strokes) and problems with the trial's design.”
It’s worth noting that Goozner’s blog drew a slew of enraged comments which seemed to be coming from investors who were stung by his analysis. In my experience as a journalist, when money is involved, and people are that angry, you have stumbled upon the truth—and struck a nerve. (If there is no reason for skepticism, investors would have ignored Goozner and Goldberg, confident that, on April 28, they would be vindicated.
Why the Times Published a Story Before Results Are Announced
As for the Times story, Gary Schwitzer’s blog, HealthNewsReview , is devastating in its accuracy:
“This story about a drug company's announcement of positive study results fails readers in every important way.
“It portrays a ‘decisive’ clinical trial that shows a first-of-its-kind prostate cancer drug ‘prolonged the lives of men.’ It spins the tale of a determined company rewarded for its persistence against a slow-witted bureaucracy, whose earlier inaction led to the loss of ‘a lot of good men.’ . . . It anticipates the drug's approval, and documents Wall Street's instant validation of the study’s findings.
“Not until paragraph eight does the story state that the company has not released the results, that the findings will not be discussed in public for two weeks, and that even then they will not have been peer-reviewed or published. It does not say that the results of this medical study were announced in a conference call to investors.
“It recklessly, even perversely, suggests that the FDA's earlier inaction, combined with patient protests and what are now claimed to be positive results, constitute proof of efficacy.
“It's hard to imagine why a story would delay and omit key information, imply efficacy had been demonstrated in the absence of evidence, or fail to balance all the positive views with those of a skeptic, or at least someone who urges prudence until the data are made public.
“It is true that this story was originally published in the paper's business section. But all journalists share a common responsibility to the public when writing stories about diseases and treatments. In today's media environment, where a story's readers usually encounter it out of context of a ‘section,’ few readers will be ‘savvy’ enough, if that is the word, to bring lower expectations of accuracy, balance and fairness to a story about what a drug can do for a deadly disease merely because it was originally written for the ‘business’ section.
“It's painful to imagine how families affected by advanced prostate cancer may respond to this article, and then to what they will subsequently learn. Even investors are badly served by such an unbalanced, incomplete story.
“In any case, it is distressing to see such credulous, feeble, negligent journalism published anywhere in the New York Times.”
I couldn’t agree more.
Full disclosure: this week I am going out to the University of Minnesota, Where Schwitzer directs the graduate program in health journalism. There, I will be screening the documentary of my book, Money-Driven Medicine,. I should add that I have praised Schwitzer’s blog in the past, long before he invited me to bring the film to Minnesota. We happen to agree on many of the most important problems in our health care system, and the way the media covers it. This is why I am so impressed by his blog, and why he was interested in the film. (I will write more about the film, and future screenings, when I come back. I hope to put clips up on HealthBeat.)
Finally, hat tip to Merill Goozner for a spot-on description of the Times piece: “science-by-press-release.” As he says, “this will only add to the pressure on the Food and Drug Administration to approve the drug, no matter what the actual data says.”
But I wouldn’t fault the reporter, and I don’t think Merrill would either. At this point, print journalists are under so much pressure to produce more, in less time, that thin reporting is inevitable. We must find a better way to support good journalism, whether in print or on the blogosphere. (I know that Merrill agrees on this point.) More institutions must pay bloggers to blog—universities, non-profit foundations like The Century Foundation and government agencies (like the OMB, which has its own blog) should fund bloggers. At the same time, the best of the print media needs to find a way to build a bridge between the world of print—which is still extremely important—and the Internet.
Bottom line: for-profit medicine will always be, well, for profit. We must change that dynamic.
It seems that the type of PR announcement that is the basis for the Times’s story should run afoul of SEC regulations.
It’s a type of insider information being used to influence stock trading. In this case the insiders are the company’s management which, for all we know, are making trades on the basis of the activity they have stimulated.
I don’t see why the SEC shouldn’t require “quite periods” just as they do in cases of new stock offerings.
Of course the SEC hasn’t been doing its job for a decade. This would be a good time to show that they have changed their attitude toward regulation
Chris & Robert
Thanks for your comments.
Robert– I agree. Companies should not annouce a medical breakthrough to analysts (who by and large are not MDs and not in a position to judge the evidence) before preesting the evidence at a medical conference, where specialists in the appropriate field can question it.
Of course the company knows that when it holds an analysts’ conference and reports great progress, the stock will soar.
This creates a great opportunity for anyone holding the stock who wants to get out–to get out at a high price.
Later, when the trial is explained at a medical conference, and published in a peer-reviewed journal, we’ll have a much better sense of whether Provenge will get FDA approval (from a much tougher FDA) and how effective the drug will be.
So the stock may plunge.
But the insiders and others shrewd enough to know that the analysts’ confernece created a great selling opportunity will be out.
It will be very interesting to see how the SEC operates under the Obama administration.
Someone needs to clean house, from top to bottom.
Chris–
Yes, we really need to get the “profit” motive out of healthcare. Inevitably, there’s a conflict of interest between producing profits for shareholders and producing effective, affordable healthcare for patients.
Healthcare is a necessity– like light and heat. That is why, if we are going to have a for-profit industry, it needs to be very tightly regulated, as in Europe.
And I’d like to see more non-profits healthcare.
Your character or lack of it can be judge simply by comparing the trash you’ve written with the REAL facts regarding Provenge as discussed by a panel of experts (not hacks like yourself) selected by the FDA.
The transcript is here: http://www.fda.gov/ohrms/dockets/ac/07/transcripts/2007-4291T1.pdf
Ms. Mahar:
Based upon your reply to Chris, it would appear you support the nationalization of medical research and development. Do you really believe that a government agency is in a position to bring novel treatments to market? That certainly strikes me as being a communist philosophy and one that has been debunked by centuries of human history. Perhaps you went a bit too far down the wrong fork in trying to make your case for the ineffectiveness of the SEC and the purported unethical nature of companies operating in the medical space but it appears you lost track of your thought process. Your comments were extremely naive an unrealistic.
Regards,
Gregg Burch
Maggie Mahar > “we really need to get the “profit” motive out of healthcare.”
Total rubbish! They’ve done that in the Soviet Union, and you can compare the healthcare and healthcare inventions made there with those in US…
To the contrary, we should get even better at using the natural profit drive of people to drive more health improvements and better healthcare. Denying people’s basic motives and drives is counterproductive at best and stupid.
Perhaps you’ve meant something very different to what you wrote? That we should take profit out of the FDA drug approval process. That those working for FDA should not go through the revolving doors between FDA and big pharma? That consultants and employees of FDA making decisions should have no conflict of interest in the area of their decision?
Or perhaps you are so used to superficial BS and shallow journalism that you don’t even understand the difference between these?
Wnn pepole commnt on this post, I think it would be very helpful if you dicclose whether you, or anyone in your family, owns the stock.
Obviously, no one has to do this, but it does speak to the credbibilty of what anyone commenting has to say.
When a person has a financial stake, it is very, very hard to be entirely unbiased.
Thanks, Maggie
Maggie-
Unfortunately, you got much, much of this story wrong, because you left out major parts of it that apparently didn’t fit your agenda. Interestingly, you failed to touch upon Dr. Howard Sherer’s 17 conflicts of interest (many of them MAJOR) that should have prohibited him from serving on the FDA’s Adviosry Panel for Provenge, if he had only disclosed them. Again, I urge you to do sufficient research to understand all of the Provenge/Dendreon story. But, as you said, you are probably best left ignored. I am a proud investor in Dendreon, because I believe in the science. I know that Provenge works. You and the rest of the world will find that out, too, soon enough. Neither am I bent or un-hinged, rather firmly planted in reality, as most other DNDN investors are, too. There are plenty of criminal and unethical activities that have happened in this story, but few of them involve investors, OR the company. Rather, the miscreants have been FDA employees, FDA Panel members, unethical journalists, Wall Street analysts and hedge funds. You will see that Provenge and Dendreon are going to change the way cancer is treated. And it is going to be a major paradigm shift. Good luck on removing the profit factor out of health care. It will NEVER happen in this country. I look forward to your retraction when the Provenge data is released on the 28th in Chicago. (by the way, did you see the data that was presented by Dendreon at a scientific conference in Denver yesterday? Just more good data that supports my assertion that Provenge works). Also, as long as we are disclosing financial information, where does the funding for your earnings come from?
Listen Maggie…The only reason drugs make it to the market is because of investor equity. Without shareholders providing the funds, companies wouldn’t even have the cash to last a month. I understand your concern with Wall St and how much of the focus is put on investors instead of patients. But you need to understand the world we live in and be a little more realistic. The world we live in revolves around money and without money, potential life saving drugs and procedures wouldn’t exist. That’s all I have to say. Thank you
Maggie,
It seems to me that you are very green when it comes to investments and conflict of interests. First and formost Dendreon is not supported by wall street in anyway… In fact wall street has been betting heavily against Dendreon, both in 2007 and now. So when you talk about wall street investors trying to dictate policy, you show how little you understand about what has been going on. Wall street has been trying to burry Provenge with all their crooked might.
Investors that have been marching and starting blogs like caretolive.com and others are small time investors, not wall street…If you think you are trying to help the small guy, you are entirely mistaken, with these articles, you are helping big wall street firms and the big chemo Pharma’s… Bottomline is this..Last time the FDA panel of experts voted 13-4 for efficacy and 17-0 that provenge was safe. Yet the FDA did something they had never done in their history, go against their advisory panel for a drug that benifited terminaly ill patients. The reversal of the advisory panel happened because a few coakroaches, namely Howard Scher, Maha Hussein, Padzur, the Cancer Letter principals, circumvented the approval process and conspired to undermined the FDA panel recommendation. They were supported by jounalist like Matt Herper and analyst like Jonathan Ashcoff who were short the stock… This time the light is shining on all of those cockroaches, and right now, you are also helping them…. Guess what the light is shining on you as well, Maggie…
Zino-
I’m not at all green about Wall Street. I was senior editor at Barron’s for more than 10 years where I wrote quite a few stories about Pharma.
I’ve also written a book about the bull market titled “Bull! A History of the Boom and Bust, 1982-2004.
Warren Buffet recommended Bull! in Berkshire Hathaway’s annual report.
(Perhaps you think Buffet doesn’t understand how Wall Street works?)
You say that Wall Street is now betting heavily against the stock.
It’s up 255% for the year. (up 4% just today)
This recent jump is, of course, due to the annoucement at the analyst’s conference– which provides a nice selling opportunity for anyone who was holding the stock, and worried that, once the evidence from the newest trial is examined in a peer-reviewed journal, it might not look so rosy.
Even if you were foolish enough to buy it at its peak in April 2007 at $24, you’re now close to getting your money back –it’s trading around $20.
Your language–calling people cockroaches because you lost money on a stock suggests you are a very poor loser.
Don’t you understand that Wall Street is a casino? You take your chances that others will agree with you as to who should win the beauty contest. (This was not a stock that was trading on fundamental values.)
John– life-saving drugs make it to the market, not because of investors’ equity but because of taxpayers’ dollars.
The majority of drugs that have made it to market in the past 15 years–and actuay represent progress–were developed by government.
For-profit companies came in at the very last stage, to reap the profits.
See the post about cancer drugs, and in the comments, the excerpt I quote from Merrill Goozner’s book, “The $800 Million Pill.” You might want to buy the book.
Teddy’s Cousin–
I work at The Century Foundation which is funded by the endowment Henry Filene left when he founded it in 1919. We are not a fund-raising foundation, so “new money” does not effect our positions and Henry is no longer around to express his opinions
Yes I did look at the Denver data.
On the outlook for Dendreon, as the company acknowledges in the boiler-plate at the end of the statement releasing that data: “this news release contains forward-looking statements that are subject to risks and uncertainties surrounding the efficacy of PROVENGE to treat men suffering from prostate cancer, risks and uncertainties surrounding the presentation of data to the FDA and approval of product applications by the FDA and risks and uncertainties inherent in the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics. Factors that may cause such differences include risks related to our limited operating history, risks associated with completing our clinical trials, the risk that the safety and/or efficacy results of existing clinical trials or from additional clinical trials for PROVENGE will not support approval for a biologics license, the risk that the FDA may interpret data differently than we do or require more data or a more rigorous analysis of data than expected, the risk that the FDA will not approve a product for which a biologics license has been applied, the risk that the results of a clinical trial for PROVENGE or other product may not be indicative of results obtained in a later clinical trial, risks that we may lack the financial resources and access to capital to fund required clinical trials or commercialization of PROVENGE, our dependence on the efforts of third parties, and our dependence on intellectual property. ”
Cancerconsultatns.com notes that “demonstration of improved survival is complicated by the availability of a variety of relatively effective salvage therapies in control patients. The obvious big advantage of Provenge over other therapies is the relative lack of toxicity.”
Btw, as you know, Provenge does not save lives–it prolongs survival. I’d still like to know more about the quality of life for these late-stage cancer patients
. Last time around, the company told the FDA that it had not looked at that question.
As for non-profit vs. for-profot health care–it’s only fairly recently that the govt has been handing its reserach over to for-profit Pharma. This could change.
Presdient Obama has made it clear that the era of health care companies over-charging Americans is over.
Akcge–Yes, I agree it would be good to put an end to the revolving door at the FDA.
But here is the real problem with U.S. healthcare: The U.S. is the only country in the developed world that has chosen to make healthcare a largely unregulated for-profit undustry.
In other countries, drug prices are regulated in various ways. Companies are not allowed to gouge as they do here.
And health care outcomes are much better in virtually all areas in countries like Sweden, Germany, France etc .
Under health care reform, many for-profit health care companies will be regulated and we will have much more unbiased information on the effectiveness of various very expensive drugs.
This is why President Obama is investing so much in “comparative effectiveness reserach”
The pharamceutical industry will no longer be able to control that information. (The reserach shows that they regularly distort it.)
Gregg–Re: government developemnt of drugs.
This is what the former head of global R&D at Hoffman LaRoche had to say in his book “In Quest of Tomorrow’s Medicine” :
where he predicts that large for-profit drugmakers wiil disappear:
“There can be no doubt that drugs could be discoverd and developed outside the pharmaceutical industry.” He then suggested that the NIH and similar entites in other countries like Germany could pick up the mantle of drug commercialization.
He adds “An industry that becomes disconnected from its true purpose will gradually become replaceable.”
What was its true purpose?
Right after WW II George W. Merck defined it.”We try never to forget that medicine is for the people. It is not for the profits.”
This is really all I have to say to all of the investors on this thread.
This reminds me of the hysterical death threats leveled at a pediatrician who dares to suggest that autism is not caused by vaccines. Obviously some buttons are being pushed–you can see it on this thread too. Shame on the TIMES. Does this mean I have to start monitoring the business section? Sigh.
Maggie, let us know when we can gt our hands on that documentary
Martha–
Thanks for you comment.
The 90-minute documentary of my book Money Driven Medicine is finallly done.
I’m going out to the university of Minnesota later this week where Gary
Schwitzer and the Jouralism school is hosting a screening.
Right now I just have one DVD, but I should have a stack by the time I come back and will send them out to people interested in doing a screening. (No charge for DVD if you’re
doing a screening–just please don’t copy it, unless you’re copying for someone else who wants to do a screening.
A screening could be 10 friends in your home–or 400 people at a health conference.
I’ll write more about this very soon.
maggie – prove you’re not just another lazy, biased journalist and respond to these points, instead of selectively choosing to respond to peoples points that fit whatever agenda you have:
1) do you refute that both scher and hussain had significant conflicts of interests? if you do, please explain how it just so happened that novacea (the company scher was principal investigator for a prostate cancer drug) signed a very lucrative partnership with big pharma for that very drug IMMEDIATELY after the provenge CR letter? this among 16 other conflicts. and oh yeah, that drug failed miserably.
2) if you truly know wall st like you claim, you would have simply looked at the short interest of dendreons stock (at points over 20%)and even the most basic novice would know that most of wall st was and is still against this company. please provide an arguement or proof where “wall st” is supporting this stock.
3) when dendreon announces the stats next week, will you retract your thrashing of the company if the numbers are as they say they are? afterall, if the numbers are suspect, the CEO, COB etc etc are insane and will face jail time for lying to the public by signing the PR
i do hope you respond to each of these points. PLEASE ADDRESS THEM AND DONT PICK AND CHOOSE.
Come on, Maggie. What analyst’s conference? It was a CONFERENCE CALL/webcast that anyone could have listened to/watched, even you! For all I know they would have allowed questions from media members. How about addressing Dr. Howard Scher’s 17 conflicts of interest?
I recall reading somewhere that Warren Buffett said he doesn’t invest in biotech because he doesn’t understand it. (forgive me if I am incorrect)Unfortunately, many stock analysts and journalists cover or write about biotech that don’t understand it either, and millions of people listen to them anyway. If you are interested in learning more about the quality of life of Provenge recipients, I encourage you to visit dendreon.com where 3 long-time survivors who received Provenge are featured. I belive that Mr. Eduardo Garcia has survived 7 years since receiving Provenge. After 7 years, I’m thinking he may be cured, but why don’t you ask him? Quality of life information is well known, the general side effects are 1-2 days of mild fever, chills or flu like symptoms. That’s it. Hence the 17-0 vote for safety by the FDA Advisory Panel (Dr’s Scher and Hussain voted positively on this question as well). Do you know that more than 50% of men refuse to have Taxotere treatment due to the horrible side effects vs. the small increase in extension of life benefit? Or that almost 2% that accept the treatment are killed by it? Maggie, all I’m asking is that if you write the story of Provenge, do the WHOLE story, not just bits and pieces that may be viewed as titilating reading. It really should be about the science. Regards.
Thanks for this great post…….