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PHARMA/POLICY: FDAWeb puts up whistleblower page

The online site FDAweb has put up a page for FDA employees who want to whistleblow on their agency. This follows the negative experience of David Graham among others who’s story is told in the initial posting.

Reg required):

In an interview on the PBS news program Now, CDER deputy director of drug safety David Graham said recently he wouldn’t recommend that anyone become a whistleblower. Yet blowing the whistle on management wrongdoing has a long, if not entirely happy, history in government service, and is protected by the Whistleblower Protection Act and by a special government office set up to enhance that status, the Office of Special Counsel. Thomas Devine head of the Government Accountability Project (GAP) which subsequently came to Graham’s aid, put it this way: "Good faith whistleblowers* represent the highest ideals of public service and the American tradition for individuals to challenge abuses of power. They live by the Code of Ethics for Government Service by ‘put[ting] loyalty to the highest moral principles and to country above loyalty to persons, party or government department’ … Even dissenters with the basest of motives can make positive contributions if their disclosures are accurate and significant. They provide the pluralisms of views and competitive diversity of information necessary for the checks and balances in a democracy."

This should be pretty interesting reading over the next little while–assuming that there are people left at the FDA other than Graham who are unhappy with the way things have been going there the last few years. Meanwhile in other FDA related news, the President and Chief Medical Advisor of the Consumers Union have an editorial in the LA Times criticizing the Administration for leaving the agency without a permanent leader. Finally, Lilly is fighting back against the claims in the BMJ over the holiday break that it withheld information from the FDA about the potential adverse effects of Prozac. However, even if Lilly is right in this case it didn’t exactly promote the information widely — it came out as part of a court case. Although if my memory serves me rightly the "church" of Scientology was pretty convinced at the time that Prozac caused suicides, long before the scandal with pediatric use of Paxil. Heaven help us if we’re relying on them for our best medical information.

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PHARMA/POLICY: FDAWeb puts up whistleblower page

The online site FDAweb has put up a page for FDA employees who want to whistleblow on their agency. This follows the negative experience of David Graham among others who’s story is told in the initial posting (Reg required):

In an interview on the PBS news program Now, CDER deputy director of drug safety David Graham said recently he wouldn’t recommend that anyone become a whistleblower. Yet blowing the whistle on management wrongdoing has a long, if not entirely happy, history in government service, and is protected by the Whistleblower Protection Act and by a special government office set up to enhance that status, the Office of Special Counsel. Thomas Devine head of the Government Accountability Project (GAP) which subsequently came to Graham’s aid, put it this way: "Good faith whistleblowers* represent the highest ideals of public service and the American tradition for individuals to challenge abuses of power. They live by the Code of Ethics for Government Service by ‘put[ting] loyalty to the highest moral principles and to country above loyalty to persons, party or government department’ … Even dissenters with the basest of motives can make positive contributions if their disclosures are accurate and significant. They provide the pluralisms of views and competitive diversity of information necessary for the checks and balances in a democracy."

This should be pretty interesting reading over the next little while–assuming that there are people left at the FDA other than Graham who are unhappy with the way things have been going there the last few years.

Meanwhile in other FDA related news, the President and Chief Medical Advisor of the Consumers Union have an editorial in the LA Times criticizing the Administration for leaving the agency without a permanent leader.

Finally, Lilly is fighting back against the claims in the BMJ over the holiday break that it withheld information from the FDA about the potential adverse effects of Prozac. However, even if Lilly is right in this case it didn’t exactly promote the information widely — it came out as part of a court case. Although if my memory serves me rightly the "church" of Scientology was pretty convinced at the time that Prozac caused suicides, long before the scandal with pediatric use of Paxil. Heaven help us if we’re relying on them for our best medical information.

PHARMA/TERRORISM: Cox-2s as the solution to finish off Al-Qaeda

Andy Borowitz’s daily Borowitz report is the funniest thing in my in-box. And never a truer word was said about the real capability of pharma DTC to change the world than today’s report which I reprint below.

CIA ATTACKS AL-QAEDA WITH PRESCRIPTION DRUGS Secret Weapon in War on Terror

The Central Intelligence Agency has implemented a new plan to destroy the al-Qaeda terror network by convincing the terrorists to start taking hazardous prescription drugs, the agency confirmed today. Within the intelligence community, hopes are high that evildoers will begin taking the medications and will soon afterwards suffer from a broad range of serious side effects, including heart attacks and death.

According to one CIA source, agency analysts developed the prescription drug strategy after they viewed a video of al-Qaeda leader Osama bin Laden walking in mountainous terrain and noticed that he seemed to be experiencing "a certain degree of joint pain."

The source said that on Monday of this week the agency launched a multimillion-dollar marketing campaign aimed at terrorists and madmen around the world, urging them to start taking several recently discredited pharmaceuticals. In one commercial currently airing on the Arabic-language al-Jazeera network, an actor portraying a terrorist says, "I was in so much pain, I just didn’t feel like going on jihad anymore."

After praising a prescription arthritis medication, however, the same evildoer is seen jumping through an obstacle course at a terror training camp, saying, "Now I wake up every morning ready to kill the infidels!" According to the CIA source, prescription drugs may be the secret weapon that the spy agency has long been looking for to win the war on terror: "The bad guys may have Anthrax, but we have Vioxx."

Elsewhere, a Colorado man who said he was optimistic about the upcoming Iraqi elections later discovered that he had a four-inch nail lodged in his skull.

PHARMA: The Industry Veteran on the chances of rational moderation from Pharma

On Friday I commented on the proposal to withdraw liability from punitive damages from pharma products approved by the FDA, and (probably vainly) appealed to responsible people in pharma-land to take at least look this gift horse closely in the mouth. The Industry Veteran was not hopeful and ascribes my perspective of naivete to my place of nativity. He writes:

The perfidious Albion shows through your plaintive call for some responsible, intelligent action from Big Pharma. You wanly hope for the industry’s Wise Men to tell their CEO peers that current policies will create a devastating backlash. The fact is, Matthew, in American industry there is no House of Lords or even a council of seasoned gentrymen to provide rational thinking and responsible, adult behavior. The fiduciary officers who run the Big Pharma companies each seek to compile a stash of +/- $100 million in a fairly short period of time and then get out while they’re still young enough to enjoy these ill gotten gains. As a result, their thinking is focused entirely on the near term and contains not a whit of concern for the industry’s long-term survival. Given that they’re indifferent to the well being of their employees, customers and, for the most part, their shareholders, it is at best naive to hope that they would value something as nebulous as a legacy. Your call for the emergence of Pharma Wise Men is as much as cry of despair and an admission of spent thinking as the bedraggled Democrats who expect a more moderate George Bush to appear during the second term because he may want to establish a legacy.

A few months ago I had a similar conversation with an acquaintance who retired from Bristol-Myers Squibb. I expressed my view about the narrow, self-serving approaches of Pharma management.

"I said the same thing to Charlie Heimbold," he told me, referring to the previous chairman of BMS. "When I mentioned the $100 million figure, Charlie stopped dead in his tracks as we were walking down the hallway and said, ‘Is that all they’re looking to get? They ought to be fired for not being ambitious enough!’"

I responded by asking how much Heimbold took with him when he retired. "It was easily $500 million," said the confidant.

HOSPITALS/POLICY: King-Drew in context, part II, with Tuesday UPDATE

Late last year there was a five part series in the LA Times about the problems at King-Drew Medical Center, and in a blog piece I tried to put it in a little context. I promised then that I would say more later and with today being Dr. Martin Luther King’s holiday, it seems like a good day to do that.

I said last month that I don’t think that race per se is at the basis of the problem, whether it’s issues between blacks and latinos (as has often been cited at King/Drew) or whites and minorities. It seems to me that an obsession with race seems to be missing some vital points about American society that are ending up reflected in things like the failure of King/Drew. These group under three predominant areas. 1) the scale of inner-city poverty and its impact on health care. 2) The relationship between community and authority. 3) The management of a large scale health care systems in a world of electoral machines.

1) Inner city poverty and its impact on health care. There isn’t too much more to be said about the impact of inner city crime and violence on facilities like King-Drew, LA County, Cook County and others. But there are several factors that are less well known. One is that the ratio of physicians to population is much lower and of course the ratio of the uninsured (and for that matter undocumented) to the general population is much greater in neighborhoods served by this type of hospital. The added costs of serving this population are to some extent recognized by the subsidies within the Medicaid program called DiSH payments (DSH stands for disproportionate share hospitals). But in the end even those with good insurance in these areas (predominantly Medicare recipients) receive services and surgery at much lower rates than those in the wealthier suburbs. One well known study focused on the extent to which blacks receive far fewer surgeries than whites, but a Dartmouth study in fact shows that it’s micro-geography that’s destiny in this case. Of course the correlation between being in a poor area and being a minority is very close, particularly in inner cities. And it’s also true that general health measures are much worse for people in those areas, with things like asthma rates in the Bronx and some parts of southern California being much worse than national averages, and even the infant mortality rate in the US overall being dragged down by what’s happening in the inner cities.

But it’s not absolute. In fact if you look at minorities who are wealthier than average (or as wealthy as average whites), as Mike Magee did late last year in his Health Politics site, you find that it’s not race but class and income that make the greatest difference in health status and outcomes:

Looking at the number of deaths per 100,000 person-years in adult men with incomes under $10,000 per year, blacks have 21 percent more deaths than whites. This difference declines to 4 percent for those with incomes from $15,000 to $25,000. But when you turn the numbers sideways, comparing whites with incomes below $10,000 with whites with incomes of $15,000 to $25,000 per year, the higher income group has 240 percent fewer deaths. A similar comparison among blacks shows 275 percent fewer deaths among those with higher incomes.

We also know that class and education has a huge bearing on health status, and greater relative levels of inequality have a big impact too. So you’d expect a greater differential in the US, than in a country with relatively greater income equality like Japan, and that’s what you get. So the end result is that if most of the poorer people are crowded into one part of a state or metro area, there will be fewer facilities and personnel to care for them, yet they’ll have worse health problems.

There’s also the physical geographic extent of this ghetto-ization. For example the series in the LA Times on King-Drew compared the LA County-owned hospitals unfavorably with the public hospitals in the SF Bay Area, but my impression is that the poor areas of Los Angeles are much larger and much more obviously segregated from the Beverly Hills and Brentwoods than those similar areas in the San Francisco area. This may be true too in, say, Chicago versus New York (but again my local knowledge is limited so I might be wrong). But my guess is that the mix of patients is poorer at King-Drew than in equivalent hospitals in many other cities.

So while King-Drew obviously has serious, serious problems, by definition any medical center serving the areas of Watts and Compton is going to have to deal with things that are outside the range of the normal American hospital experience.

2) The relationship between community and authority. One of the major themes coming through in the LA Times series is the lack of the trust between the local activists in Watts (who represent "the need") and the LA County Board of Supervisors (who represent "the money"). Part of this is based on race. I remember the Harris Poll some months before the OJ verdict that showed that 65% of black Americans thought OJ was set up while something like 61% of whites thought he was guilty, which gave you a hint as to how things were going to go with a majority black jury. Los Angeles is the city of the Watts riot, the CIA’s involvement (however peripheral) in the crack epidemic, the Rodney King beating and later riots and the Rampart cops scandal. There isn’t exactly a lot of trust between the haves and the have-nots. Again I’m too much of a traditional sociologist to be convinced this is entirely race and culture-based. For example back in my home town of London I was told by a barrister (trial lawyer) back in the 1980s that the conviction rate by a jury for burglary in the Crown Court in Knightsbridge was 75% while in the poor East End neighborhood of Shoreditch it was under 25%. The joke was that wealthy jurors in Knightsbridge were convinced that the burglar might be trying to steal their VCR, while in Shoreditch the jurors would expect to be able to buy that VCR cheap from the thief. All joking aside, there are examples all over the American west of small predominantly white communities that don’t trust outsiders and authorities without going all the way and becoming the next Timothy McVeigh. So I’m not convinced that the conflict between the LA County and the people in Watts is just about race. But it certainly is between those who are out of power and those who control it. And of course if King-Drew were to go away, part of the raison d’etre of that struggle overall would go with it.

3) The management of a large scale health care systems in a world of electoral machines. Finally, whenever you have a huge public health system like that of New York or Los Angeles, you are going to inevitably have to deal with the politicization of running it. Just understanding the bureaucracy of hiring and firing in these huge government departments boggles the mind of those of us used to the private sector. The delivery of favors and appointments in returns for influence, votes, and union members’ electoral work continues to be standard practice in most city governments in the US (and has its direct equivalent at a national level!). When so much of the budget flows into the health system, it is by its nature going to get politicized. That politicization may involve using the poverty of health system as a political pawn to blackmail the politicians to handing over more funds (Santa Clara Valley Medical Center’s Bob Sillen is a master at this), or it may be simply having the hospital as a focus for wider community activism.

The key is that the hospital is very visible as an employer and as a community resource. Even if the hospital was taken away in return for fair and complete subsidies for other care or coverage, no one responsible for care for the poor in America today is going to agree to that swop. Why not? Because you can’t parade a cut in a subsidy or a tax credit on the news, but you can show a hospital ward that has to close. And the legitimate concern of everyone in Watts is not just how bad is King-Drew, but what would they replace it with? And the answer in today’s America may be something much less.

UPDATE: The LA Times reports Tuesday that the LA County Board of Supervisors are prepared to put the running of King-Drew in the hands of an independent board.

PHARMA: Quick blog trawl, with UPDATE

A quick trawl of the blogs this morning finds me catching up on an excellent article on the present and future of DTC from John Mack at the Pharma Marketing Blog, and discovering a new anti-pharma blog called Pharmopoly. Obviously take this with a pinch of salt but here is what the anti-globalization folks at Pharmopoly are saying, and note that drug companies are now moving squrely into their cross-hairs over patnets and reimportation as well as over thrid world imports:

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PHARMA: Herbert on the legal protection measure for big pharma

In a NY Times op-ed piece called A Gift for Drug Makers, Bob Herbert writes that:

Tucked like a gleaming diamond in proposed legislation to curb malpractice lawsuits is a provision that would give an unconscionable degree of protection to firms responsible for drugs or medical devices that turn out to be harmful. The provision would go beyond caps on certain damages. It would actually prohibit punitive damages in cases in which the drug or medical device had received Food and Drug Administration approval. We know the F.D.A. has failed time and again to ensure that unsafe drugs are kept off the market. To provide blanket legal protection against punitive damages in such cases is both unwarranted and dangerous.

In fact the former head legal counsel at FDA Daniel Troy already pushed this policy–changing years of precedent at the FDA–by making it take the drug-makers side in legal cases. As California Health line reported when he finally quit late last year:

During his tenure, Troy worked in support of Bush administration efforts to block liability lawsuits against medical device manufacturers and drug makers. Troy argued in legal briefs that only FDA has the authority to determine when and how pharmaceutical companies should issue product warnings and that state court decisions could undermine the agency’s authority over product labels. FDA claimed in briefs that suits against FDA-approved products would "sabotage the agency’s authority"; critics called the agency’s position a "back-door approach to tort reform."

While no one who’s been awake in the last 4 years can pretend to be surprised about how much the Bush administration is determined to gift the pharma industry, one suspects that someone in the corridors of power up and down the New Jersey turnpike must be having some doubts. As one of the few "moderates" clinging to the lonely position that pharma is indeed responsible for most of the good innovations in the health care system, and that a rational, reasonable and profitable pharma business is possible without the need to push for the current excesses on pricing and marketing misbehavior, I’ve been suggesting that in its own longer term interests pharma should look to compromise. If instead big pharma believes that it can make itself completely immune to the American legal system by simply getting what looks increasingly like a bought-and-paid-for FDA to sign off on its behavior, then the backlash that will be coming big pharma’s way when its protectors at either end of Pennsylvania avenue get booted out will not be pretty. And at some point they will be booted out.Even Wall Street is generally comfortable that one of the risks of investing in pharmas is that damages will have to be paid out if bad things happen. Investors in Merck know that there’s a payment coming down the line for Vioxx and the stock reflects that. It’s stretching credulity to believe that pharma really needs this protection when no one else in America gets it, and it may well be time for wiser heads in New Jersey to suggest to their brethren that they take their snouts out of the trough less they miss the farmer coming up behind them with the butcher’s knife.

PHARMA: The FDA can only be saved by new leadership, by Blunter

There’s a new contributor today on THCB. Blunter worked at the FDA for many, many years and understands from the inside many of the problems with the agency that have been documented in many places, such as this Forbes article. He responded to my notion that the problem is simply the speed of the drug approval process and suggests that the issues go way deeper. What he says about the management of the agency, the culture of secrecy and the information obfuscation is well worth taking seriously:

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TECHNOLOGY/CONSUMERS: iHealthBuzz–new site for community messaging

There’s a relatively new site for patients called iHealthBuzz. It’s in the mix with the social networking sites that I keep the odd tabs on, and looks to try to take the disease specific list-servs up a level, although obviously its got a long way to go before it takes over from WebMD or YahooHealth. Is there a need for yet another health discussion venue? Judge for yourself but here’s founder Ellen’s take:

Our goal is to provide an anonymous (email address optional),friendly, useful, free, and trusted environment for those who are in search of health advice, support, and discussion. We are also nonprofit so we don’t try to sell anything at all. As we are a grassroots site that really has started out as a hobby for many of us who are interested in using the Internet to promote health. We created this site to help people. We want to make iHealthBuzz message boards better also. Any ideas will also help. We are here to provide a useful service.

Our goal: To build a busy virtual "cafe" or meeting place where people are connecting around health issues. We want them to share stories and help each other. We hope to create a buzz about health on the internet. Hence i-health-buzz as the name.

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