A New Team at the FDA — Sharfstein’s Critics

Over the week-end, when I heard that President Obama had selected Margaret  Hamburg as FDA commissioner and Joshua Sharfstein as deputy commissioner, I began Googling “Sharfstein.”  I already had read about Hamburg and I knew the former New York City health commissioner has earned very high marks. 

But I didn’t know much about Sharfstein. So my heart sank when I read this in the “Comment” section of yesterday’s Guardian: “Although Dr Margaret Hamburg, the nominee for commissioner, boasts significant experience in government and is highly thought of in the public health community, her new deputy, Dr. Joshua Sharfstein, is an inconceivably poor choice.”

Reportedly, Sharfstein is going to be the point man regulating drugs and devices. Meanwhile Hamburg  will ovesee food safety and tobacco—if the agency wins some control over the substance. (According to the Wall Street Journal, a bill that puts tobacco under FDA regulation seems poised for passage next session).  Given how the FDA’s work will be divided, Sharfstein’s appointment becomes extremely important. Indeed,  the “Comment” in the Guardian notes: “from the vantage point of industry and patients, this would make Sharfstein a far more influential figure than his nominal boss – but without requiring confirmation by the Senate.” Here they seem to be implying that the Obama administration is trying to slip a weak candidate past the Senate.

But then the article’s authors, Jeff Stier and Henry Miller set out to explain why they object to Sharfstein. And at this point, I begin to smile.They portray Pharma as an industry that has been bullied, by the government and the press: “The new FDA leadership must  confront a trend that has become popular – especially among members of Congress and the media – of vilifying drug companies, and even alleging that regulators have become too cosy with industry.”  Imagine that.

“It's too bad” they write, “that Sharfstein has such a long history of hostility toward the pharmaceutical industry. While a medical student at Harvard, he led a campaign urging classmates to return textbooks donated by a pharmaceutcal company. According to the university's newspaper, Sharfstein and his group alleged that the texts ‘are paid for by consumers in the form of higher drug prices. Accepting gifts from companies violates an ethical obligation to our future patients.’ They set up a drop-box, where, like a gun amnesty program, students were urged to return the books.”

Clearly, the man is a menace. I am reminded of those wild-eyed medical students who created “No Free Lunch,” an organization that calls on doctors and med students to refuse gifts from drug-makers and device-makers. 

Granted, according to Iowa’s Senator Chuck Grassley, those lunches, dinners,  resort vacations and consulting fees can add up: “to tens of thousands and even hundreds of thousands of dollars each year. That’s right – hundreds thousands of dollars for one doctor! . . .Companies wouldn’t be paying this money,” the Senator added, “unless it had a direct effect on the prescriptions doctors  write, and the medical devices they use.” And of course, pharamceutical companies are forced pass the cost of those gifts and vacations on to customers in the form of higher prices. (If they didn’t, their generosity could put a dent in their bottom line—and that would be unfair to shareholders.) 

Steir and Miller then report that after Harvard, Sharfstein  “went on to work as health policy advisor to Democratic congressman Henry Waxman of California, who personifies the divisive approach that castigates and persecutes innovative pharmaceutical companies." (Sharfstein was an investigator on Waxman’s previous committee, Government Reform and Oversight.)

More recently, “As the public health commissioner in Baltimore, Sharfstein engaged in typical functions of a city health commissioner, such as going after lead in candy,” they report. “But he also (reasonably) advocated against marketing cold medicines to children under four, where there was little evidence of efficacy.”

I’m glad to hear the authors agree that we shouldn’t encourage parents to let their 3-year-olds get stoned on over-the-counter cough and cold medications that can cause both hallucinations and cardiac events in tiny bodies.  So what exactly is their objection to how Sharfstein performed in Baltimore? That we went after lead in candy? (There are the only specifics they mention about his tenure in the job .) 

Too Much Regulation In Washington In Recent Years?

It seems that the root of their dissatisfaction lies in how the FDA has been treated in the past:
“the new leadership will face the added challenge of addressing the legacy of recent incumbents – who imposed excessive and expensive burdens on those trying to bring new medicines to consumers, pushed drug development costs into the stratosphere, damaged agency morale and permitted the drug approval process to become politicized.”

A legacy of excessive regulation? That is not the Bush administration that I remember. Nor is it the FDA that I have been reporting on in recent years. In October of 2007, I talked to a source inside the agency who explained that since the FDA has committed to reviewing applications for approval of a new drug within 10 months, the burden on drug-makers has lightened. Companies have begun submitting “shabbier” applications that contained less evidence about risks and benefits.

 “For the drug-maker it’s a gamble,” he confided. “The company is betting that, because we want to make the 10-month deadline, we won’t send the application back.”  And often, he acknowledged, the company is right. “If you find a problem or there is something missing and it doesn’t seem terribly material, there is a tendency to overlook it. Because if you don’t it will just delay the whole process.”

In the past, he added, a company submitting an application knew that if the application wasn’t up to snuff, the FDA would send it back. But those standards have fallen: “Now we send it back [only] if it’s really crappy.”

In 2008, the New England Journal of Medicine published a piece that confirmed what I had been hearing.  In “Sidelining Safety—The FDA’s Inadequate Response to the IOM,” Sheila Weiss Smith, an associate professor at the Center on Drugs and Public Policy at the University of Maryland’s School of Pharmacy who  has sat on a number of FDA panels, criticizes the  agency’s failure to “embrace a culture of safety.”

Smith argues that “accelerated development programs and expedited reviews” make sense to “hasten the introduction of lifesaving drugs . . .  but they should not be an option for treatments intended for chronic conditions. Drugs designed to treat chronic diseases should have safety standards that tolerate minimal uncertainty.”  Nevertheless, she points out,  the FDA has been interpreting the 1992 Prescription Drug User Fee Act (which called for faster approvals) very broadly, and as a result, “drugs for the treatment of common chronic conditions such as diabetes (troglitazone), obesity (dexfenfluramine), and pain (rofecoxib) were approved under expedited programs– and later were withdrawn from the market for safety reasons."

Too often, the FDA’s language reveals its skewed priorities. Responding to an IOM  recommendation that “scientists with expertise in pharmacoepidemiology or public health be included as regular members of all scientific advisory committees”  the agency replies that it would include such expertise "when safety issues are an important component of the issues before the Committee."

 “But safety should always be on the agenda!” Smith exclaimed.

Hard Times for the Industry 

Still, as  Stier and Miller point out, “these are difficult times for the  drug industry.”  Click on “difficult times” and the author take you to a paper that inveighs against the recent “obsession with conflict of interest” among “conflict of interest activists.” These are the folks who find it problematic when scientists who have financial ties to for-profit industry serve on government advisory panels that will be making decisions that affect that industry.  Among the “activists,” the Union of Concerned Scientists comes in for special censure. Always curious, I Googled the group, and I must admit that I can see why Stier, Miller and those who share their views would be troubled:

In 2006 the Union of Concerned Scientists surveyed scientists within the FDA. Consumersunion.org, the non-profit publisher of Consumer Reports reveals what they found:

— Three in five scientists knew of cases where commercial interests inappropriately attempted to change an FDA action;

— One fifth say they were asked by FDA decision makers to provide “incomplete, inaccurate or misleading information to the public;”

— Nearly two in three said that the laws and regulations that govern the FDA need “change for the agency to better serve the public;”

 – Just half felt the FDA is acting effectively to protect the public health;

Adding to Pharma’s woes, Stier and Miller points out that “development costs are up while approvals are down.” This is true—and you might wonder why. 

It turns out that development costs are steep because for a couple of decades, drug companies haven’t worried about expenses. As an insitutional investor explained to me when I was writing Money-Driven Medicine: “If you have profit margins of 25 percent, who cares how much you spend? Of course no one wants to re-think the business model,” he admitted . . . “But if you did think about it, you would see a great deal of waste.”

In fact, drug makers have begun trimming the legions of drug reps who visit doctor’s offices.

“Frequent visits are not well received anyomore, “ acknowledged a Wyeth spokesman a few years ago. This was an understatement. Physicians were so fed up with seeing sales reps in their waiting rooms that drug-makers were committing “death by salesperson,” quipped Sanford Bernstein stock analyst Richard Evans.

Now, further belt-tighteing is in order, one insitutional investor told me. “It might mean doing clinical trials in Poland, the Ukraine or South Afraica—where you can do them for 20 to 30 percent less than in the United States. It might require shifting manufacturing to Singapore..” He realized that these ideas are controversial. Shipping jobs abroad does not seem good public policy, particularly in the midst of a recession.

Nevertheless, it is true that when other industries down-sized, drug-makers let costs spiral—they believed they could also pass their expenses along in the form of higher prices on blockbuster drugs. But now, fewer  blockbusters are being approved. 

And this isn’t because FDA regulations have tightened. It is because drug companies have fewer innovative new products in the pipeline. For years, exciting new discoveries were coming to market.  But now the industry has picked the low-hanging fruit. The next generation of truly new drugs will probably depend on basic research that is now in its infancy. Meanwhile, American patients have accepted generics, and, in some cases, the companies that make them are eating Pharma’s lunch.

Still, Stier and Miller seem to think that it’s up to the FDA to bail out the industry: “Leadership at the FDA will demand nuance and the ability to weigh benefits and risks – including the risks of excessive regulation. Federal regulators should not be collaborators with industry, to be sure, but they must cooperate with drug manufacturers in order to get new drugs to patients in a timely and cost-effective way.” 

If there are effective new durgs to approve, then I agree the FDA should help get them to the public. But if pharmaceutical companies are running out of ideas, what should the agency do—invent products for them?

“Sharfstein does not have any experience with the arcane and high-risk business of developing and regulating prescription drugs,” the authors grumble. Here, they seem to forget, developing drugs is not his job. 

“He is far more likely to waste time and energy collaborating with activists who wish to end free drug samples to consumers,” they fret. Well, yes, this is part of  his job description—protecting the public.  Too often, those  free samples  get consumers “hooked” on the most expensive drugs, when a  less expensive pill would provide the same benefits without risking unknown long-term side effects.  But have you noticed, drugmakers rarely give doctors “free samples” of those reliable older drugs?  Instead, they recommend that the doctor give you enough of the new pill to “get started,” and a prescription for of the rest. In many cases, the patient won’t know that there is a  much cheaper alternative unless he asks his pharmacist: “Why is the co-pay $40?”

Sharfstein’s critics have one final complaint: They fear that the he may be reluctant to appoint experts to the FDA’s advisory committee panels if they have taken money from the manufacturer. “Would he hold avowed anti-industry scientists to the same tough standards?” they ask.

Here, I have two questions:  why create even the appearance of conflict of interest by putting experts who have a financial relationship with the manufacturer on a panel that judges the safety and efficacy of his product? There are, in fact, a great many physicians in this country who are not encumbered with financial ties to drugmakers. And secondly, what would it mean to hold so-called  “anti-industry scientists” (those folks who worry about conflict of interest) to the same standard? Are they suggesting that the FDA should exclude members of the Union of Concerned Scientists? I am afraid they are.

When I came to the end of their “Comment,” I couldn’t help but wonder, just who are Henry Miller and Josh Steir? The Guardian makes it easy to find out: just click on the name in the byline and you discover that Henry Miller is an M.D. molecular biologist who is also fellow at the Hoover Institution, Stanford University’s well-known conservative think tank.

As for Jeff Stier, the “Comment’s” lead author, he is the associate director of the American Council on Science and Health. What is the American Council on Science and Health? According to Sourcewatch,  ACSH describes itself as a non-profit tax-exempt  “consumer education consortium concerned with issues related to food, nutrition, chemicals, pharmaceuticals, lifestyle, the environment and health.”

And where does ACSH stand on nutrition, chemicals, pharmaceuticals, the environment and health?   ACSH  takes “a generally apologetic stance regarding virtually every health and environmental hazard produced by modern industry,” Sourcewatch reveals,“ accepting corporate funding from Coca-Cola, Kellogg, General Mills, Pepsico, and the American Beverage Association, among others.

“The organization has been a fixture on the anti-environmental scene . . . , downplaying risks from DDT, dioxin, asbestos, and a host of other polluting chemicals.  ACSH  has opposed government labeling restrictions on food additives such as saccharin and nitrites – ‘because there is no adequate data to support the hypothesis that these substances pose a risk to human health.’"  ACSH also has spoken out against a proposed 1% tax on junk foods. Finally, while ACSH has been consistently anti-tobacco, in 1980 the organization’s co-founder wrote to tobacco giant Philip Morris seeking financial support. "We are a voice of scientific reason in a sea of pseudo science, exaggeration and misinformation. We believe it would be to your benefit to help ACSH.” 

One can only wonder what “benefit” he was alluding to?

The say you can know a man by his enemies. I’m really beginning to like Josh Sharfstein.

14 thoughts on “A New Team at the FDA — Sharfstein’s Critics

  1. Having worked for Dr. Sharfstein at Baltimore City I will say that I have mixed feelings about his appointment. As for ‘protecting’ the health of consumers, I agree that he will probably be strong. I do feel, though, that ‘protecting’ will mean there is little to no access for new/experimental medications and that many people will be forced to suffer because treatments (either new/experimental or off-label) that should be investigated are summarily dismissed as unsafe. He is a powerful advocate, and has a tendency to get wrapped up in causes (such as the children’s cough syrup instance) at the expense of any other work (like being the health commissioner of a city with massive public health issues). If that becomes his full-time area of focus things might be fine, but as I said, I’m a little concerned that his level of comfort with new treatments will mean massive restrictions on what is available, even in clinical trials.

  2. The pharmaceutical industry -once a miracle industry- has gone very sour because of arrogance and greed.Furthermore they have squandered the trust of thinking Americans.
    I hope Sharfstein is not at all shy about reining them in.
    From a pure economic standpoint we cannot afford their expensive meds, there is little in their product pipelines, bio-tech products will not come on stream soon enough, and fundamentally they are an increasingly a regulated industry and should be.
    Dr. Rick Lippin

  3. Hootsbuddy, Anon, lisa, Dr. Steve,
    Thanks for the head’s up.
    When I sent it to someone to post, I inadvertently left a chunk of rough draft at the bottom of the page (you had to scroll down quite a bit to see it)
    So that’s why you got the repetition after the ending.
    Is it fixed now?
    Also, I couldn’t find the e-mail you were referring to? (my e-mail is mahar@tcf.org)
    If you look at all fo the products and devices that have been withdrawn from the market in recent years—after killing a great many people–it’s pretty clear that the FDA has erred in the direction of putting products on the market before they are fully tested.
    If an individual wants an experimental durg, they can apply for a clinical trail. That’s where experimental drugs should be tested.
    They shouldn’t be dumped on the marketplace and advertised on TV so that patients who have no idea that they are taking something not fully tested buy them.
    I realize that not all patients qualify fora clinical trial. Often this is because they are too sick, or suffering from more than one disease.
    Often there is simply no hope for patients who are turned down.
    This is very, very sad. Many patients and families have a hard time accepting the fact that a patient is dying– or has an incurable, progressive disease.
    As for Baltimore’s public health problems: they are far geater than one man could possible solve.
    The basic problem is extreme poverty. Then there is the city’s drug problem (directly related to poverty) and poor school system (directly related to poverty.
    See “The Wire”– the best dramatic series ever aired in America.
    We need a war on poverty–in Baltimore and in America– and a war on drugs that is not a war on drug addicts.
    See my post on Health Education and Welfare, and part 2 of the post, coming soon.
    At least he saved a great many young chilren from being harmed by cough syrup and cold medications. This, in and of itself, was an accomplishment. Sometimes you have to pick out one thing that you think you can do, and do it.
    For Hamburg, in NYC, it was focusing on tuberculosis.
    Lisa —
    Thanks. Yes, people should read the Bayh-Dole post.
    It explains much that is wrong with the drug industry.
    Dr. Steve
    I agree: Pharma has lost much of our trust. This is one reason why they are having a hard time financially.
    Americans are not quite as quick to buy every blockbuster they see advertised on TV. We’re becoming more skeptical.

  4. Only industry apologists like Stier and Miller would claim fostering innovation and protecting the public from unsafe products are mutually exclusive. Most industry people that I’ve talked to over the years understand that when it comes to food and drugs, a strong pro-consumer regulator is actually beneficial to industry’s long-term interests.
    The great pro-consumer reforms of the 20th century — the 1938 drug safety law and the 1962 efficacy law — led industry to a higher level of scientific competence and fostered innovation. The question now is whether the Obama administration’s new team understands the historic role that regulation has played in generating medical progress and has the courage to adopt new rules that will, in the end, be beneficial to those seeking to generate medical breakthroughs.

  5. Looks good now. All clean and pretty in a Word document.
    (I keep a blank, formatted, two column page to copy/paste/print items too long to read from the monitor. Maybe one day technology will invent a portable monitor to take to the loo.)
    The email I was referring to is the return to a note you were kind enough to send me last week.
    I’ll change to the one you cited.

  6. Merrill & Hootsbuddy–
    Good to hear from you-thanks for commenting.
    Yes, I totally agree: ”
    “a strong pro-consumer regulator is actually beneficial to industry’s long-term interests.”
    But the key phrase is “long term.” Industry folks I’ve talked to over the years– and the people on Wall Street who set expectatons for profits– don’t take a long-term view.
    There are of course, a handful of very intelligent heatlhcare analysts on Wall Street (and in London). And at drug companies there are researchers who are true scientists.
    But when I think of Pharma CEOs and executives in the U.S., I have a very hard time thinking of any with integrity.
    At one time, Merck may have put “people before profits,” but that was a long, long ago.
    Sorry to be so negative, but as you blog and book reveals this is an indusry that needs regulation.
    Thanks much.

  7. I’ve known Josh Sharfstein for twenty years and I can not think of a single other individual who I would rather have in a senior health policy capacity. He frankly doesn’t give a crap about anything other than promoting public health. That’s what we need in FDA leadership.